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SHOULDER INNOVATIONS, INC.
CIK: 0001699350  ·  File(s): 333-288549, 377-07913  ·  Started: 2025-07-24  ·  Last active: 2025-07-28
Response Received 4 company response(s) High - file number match
UL SEC wrote to company 2025-07-24
SHOULDER INNOVATIONS, INC.
Offering / Registration Process Regulatory Compliance Related Party / Governance
File Nos in letter: 333-288549
CR Company responded 2025-07-25
SHOULDER INNOVATIONS, INC.
Offering / Registration Process Related Party / Governance Financial Reporting
References: July 24, 2025
CR Company responded 2025-07-28
SHOULDER INNOVATIONS, INC.
Offering / Registration Process Regulatory Compliance Business Model Clarity
File Nos in letter: 333-288549
CR Company responded 2025-07-28
SHOULDER INNOVATIONS, INC.
Offering / Registration Process
File Nos in letter: 333-288549
CR Company responded 2025-07-28
SHOULDER INNOVATIONS, INC.
Offering / Registration Process
File Nos in letter: 333-288549
SHOULDER INNOVATIONS, INC.
CIK: 0001699350  ·  File(s): 377-07913  ·  Started: 2025-07-03  ·  Last active: 2025-07-09
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2025-07-03
SHOULDER INNOVATIONS, INC.
Financial Reporting Regulatory Compliance Internal Controls
CR Company responded 2025-07-09
SHOULDER INNOVATIONS, INC.
Financial Reporting Internal Controls Regulatory Compliance
References: July 3, 2025
SHOULDER INNOVATIONS, INC.
CIK: 0001699350  ·  File(s): 377-07913  ·  Started: 2025-06-09  ·  Last active: 2025-06-09
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-06-09
SHOULDER INNOVATIONS, INC.
Financial Reporting Internal Controls Regulatory Compliance
SHOULDER INNOVATIONS, INC.
CIK: 0001699350  ·  File(s): 377-07913  ·  Started: 2025-05-15  ·  Last active: 2025-05-15
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-05-15
SHOULDER INNOVATIONS, INC.
DateTypeCompanyLocationFile NoLink
2025-07-28 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process Regulatory Compliance Business Model Clarity
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2025-07-28 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process
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2025-07-28 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process
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2025-07-25 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process Related Party / Governance Financial Reporting
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2025-07-24 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913
Offering / Registration Process Regulatory Compliance Related Party / Governance
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2025-07-09 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Financial Reporting Internal Controls Regulatory Compliance
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2025-07-03 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913
Financial Reporting Regulatory Compliance Internal Controls
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2025-06-09 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913
Financial Reporting Internal Controls Regulatory Compliance
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2025-05-15 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-07-24 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913
Offering / Registration Process Regulatory Compliance Related Party / Governance
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2025-07-03 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913
Financial Reporting Regulatory Compliance Internal Controls
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2025-06-09 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913
Financial Reporting Internal Controls Regulatory Compliance
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2025-05-15 SEC Comment Letter SHOULDER INNOVATIONS, INC. DE 377-07913 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-07-28 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process Regulatory Compliance Business Model Clarity
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2025-07-28 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process
Read Filing View
2025-07-28 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process
Read Filing View
2025-07-25 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Offering / Registration Process Related Party / Governance Financial Reporting
Read Filing View
2025-07-09 Company Response SHOULDER INNOVATIONS, INC. DE N/A
Financial Reporting Internal Controls Regulatory Compliance
Read Filing View
2025-07-28 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP
 1
 filename1.htm

 Document July 28, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, DC 20549 Attn: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. (the “Registrant”) Registration Statement on Form S-1, as amended (File No. 333-288549) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between July 24, 2025 and the date hereof, approximately 2,840 copies of the Preliminary Prospectus, dated July 24, 2025, were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement, as amended. We wish to advise you that the participating underwriters have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Wednesday, July 30, 2025 or as soon thereafter as practicable. [signature page follows] Very truly yours, MORGAN STANLEY & CO. LLC GOLDMAN SACHS & CO. LLC PIPER SANDLER & CO. As representatives of the Underwriters MORGAN STANLEY & CO. LLC By: /s/ Chris Rigoli Name: Chris Rigoli Title: Managing Director GOLDMAN SACHS & CO. LLC By: /s/ Lyla Bibi Maduri Name: Lyla Bibi Maduri Title: Managing Director PIPER SANDLER & CO. By: /s/ Neil Riley Name: Neil Riley Title: Managing Director [Signature Page to Acceleration Request Letter]
2025-07-28 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP
 1
 filename1.htm

 Document Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, Michigan 49507 July 28, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Registration Statement on Form S-1, as amended (File No. 333-288549) Request for Acceleration of Effective Date To the addressees set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, Shoulder Innovations, Inc. (the “ Company ”) hereby requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-288549) (as amended, the “ Registration Statement ”). The Company respectfully requests that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on July 30, 2025, or as soon as practicable thereafter, or at such other time as the Company or its legal counsel may request by telephone to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Ross McAloon at (714) 755-8051. Thank you for your assistance in this matter. [ Signature page follows ] Sincerely, Shoulder Innovations, Inc. By: /s/ Robert Ball Name: Robert Ball Title: Chief Executive Officer and Executive Chairman cc: Jeffrey Points, Chief Financial Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-28 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP
 1
 filename1.htm

 Document Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, Michigan 49507 July 28, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Registration Statement on Form S-1, as amended (File No. 333-288549) Request for Acceleration of Effective Date To the addressees set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, Shoulder Innovations, Inc. (the “ Company ”) hereby requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-288549) (as amended, the “ Registration Statement ”). The Company respectfully requests that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on July 30, 2025, or as soon as practicable thereafter, or at such other time as the Company or its legal counsel may request by telephone to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Ross McAloon at (714) 755-8051. Thank you for your assistance in this matter. [ Signature page follows ] Sincerely, Shoulder Innovations, Inc. By: /s/ Robert Ball Name: Robert Ball Title: Chief Executive Officer and Executive Chairman cc: Jeffrey Points, Chief Financial Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-25 - CORRESP - SHOULDER INNOVATIONS, INC.
Read Filing Source Filing Referenced dates: July 24, 2025
CORRESP
 1
 filename1.htm

 Document 650 Town Center Drive, 20th Floor Costa Mesa, California 92626-1925 Tel: +1.714.540.1235 Fax: +1.714.755.8290 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Washington, D.C. Madrid July 25, 2025 VIA EDGAR AND ELECTRONIC MAIL Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Amendment No. 2 to Registration Statement on Form S-1 Submitted July 24, 2025 CIK No. 0001699350 To the addressees set forth above: On behalf of our client, Shoulder Innovations, Inc. (the “ Company ”), set forth below is the Company’s response to the comment of the Staff (the “ Staff ”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “ Commission ”) in its letter dated July 24, 2025, relating to the Company’s Amendment No. 2 to Registration Statement on Form S-1 publicly filed on July 24, 2025 (“ Amendment No. 2 ”). Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR Amendment No. 3 to the Registration Statement on Form S-1 (the “ Amendment No. 3 ”) responding to the Staff’s comment and updating its disclosures in Amendment No. 3. July 25, 2025 Page 2 All terms used but not defined herein have the meanings assigned to such terms in Amendment No. 3. For ease of reference, we have set forth the Staff’s comment and the Company’s response below. Amendment No. 2 to Registration Statement on Form S-1 Underwriting, page 194 1. We note your disclosure that “[you] have requested that the underwriters make issuer directed allocations in the aggregate of shares of [y]our common stock to certain investors." Please advise whether any specific investors have been identified, and if so, revise your disclosure to identify these investors and to note the number of shares of common stock to be allocated to each. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 194 of Amendment No. 3. ********* July 25, 2025 Page 3 We hope that the foregoing has been responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (714) 755-8051 with any questions or further comments you may have regarding this filing or if you wish to discuss the above. Sincerely, /s/ Ross McAloon Ross McAloon of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) Robert Ball, Chief Executive Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-24 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 July 24, 2025

Robert Ball
Chief Executive Officer
Shoulder Innovations, Inc.
1535 Steele Avenue SW, Suite B
Grand Rapids, MI 49507

 Re: Shoulder Innovations, Inc.
 Amendment No. 2 to Registration Statement on Form S-1
 Filed July 24, 2025
 File No. 333-288549
Dear Robert Ball:

 We have reviewed your amended registration statement and have the
following
comment.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments.

Amendment No. 2 to Form S-1
Underwriting, page 194

1. We note your disclosure that [you] have requested that the
underwriters make issuer
 directed allocations in the aggregate of shares of [y]our common stock
to certain
 investors." Please advise whether any specific investors have been
identified, and if
 so, revise your disclosure to identify these investors and to note the
number of shares
 of common stock to be allocated to each.
 Please contact Li Xiao at 202-551-4391 if you have questions regarding
comments on
the financial statements and related matters. Please contact Juan Grana at
202-551-6034 or
Jane Park at 202-551-7439 with any other questions.
 July 24, 2025
Page 2

 Sincerely,

 Division of Corporation Finance
 Office of Industrial Applications and
 Services
cc: Ross McAloon, Esq.
</TEXT>
</DOCUMENT>
2025-07-09 - CORRESP - SHOULDER INNOVATIONS, INC.
Read Filing Source Filing Referenced dates: July 3, 2025
CORRESP
 1
 filename1.htm

 Document 650 Town Center Drive, 20th Floor Costa Mesa, California 92626-1925 Tel: +1.714.540.1235 Fax: +1.714.755.8290 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Washington, D.C. Madrid July 9, 2025 VIA EDGAR AND ELECTRONIC MAIL Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-6010 Attention:    Al Pavot Li Xiao Juan Grana Jane Park Re:    Shoulder Innovations, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted June 18, 2025 CIK No. 0001699350 To the addressees set forth above: On behalf of our client, Shoulder Innovations, Inc. (the “ Company ”), set forth below are the Company’s responses to the comments of the Staff (the “ Staff ”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “ Commission ”) in its letter dated July 3, 2025, relating to the Company’s Amendment No. 2 to Draft Registration Statement on Form S-1 submitted on June 18, 2025 (“ Amendment No. 2 ”). Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR Amendment No.1 to the Registration Statement on Form S-1 (the “ Amendment No. 1 ”) responding to the Staff’s comments and updating its disclosures in Amendment No. 1. The Company’s responses set forth in this letter are numbered to correspond to the numbered comments in the Staff’s letter. All terms used but not defined herein have the meanings assigned to such terms in Amendment No. 1. For ease of reference, we have set forth the Staff’s comments and the Company’s response for each item below. July 9, 2025 Page 2 Amendment No. 2 to Draft Registration Statement on Form S-1 Reverse Stock Split, page 13 1. As a reminder, please note the guidance in SAB 4:C and SAB 4:D regarding your impending stock split. Response: The Company respectfully acknowledges the Staff’s comment and confirms that it will consider SAB 4:C and SAB 4:D when it updates its historical financial statements and disclosure in a subsequent pre-effective amendment to the Registration Statement on Form S-1 once the reverse stock split has been completed. Critical Accounting Policies and Estimates, page 98 2. We have read your response to prior comment 4. Given the materiality of your inventory balance, please expand your disclosure to quantify the extent to which the asset account includes products for which there were no material sales during the most recent period. Reconcile this data with your conclusion that your March 31, 2025 inventory reserve is adequate. Your existing disclosure acknowledges the existence of aged inventory but does not provide any context enabling a reader to gauge their significance relative to the corresponding reserves. The risk factor on page 20 appears relevant in this regard. See Item 303(b)(3) of Regulation S-K. Response: In response to the Staff’s comment, the Company has revised the critical accounting policy disclosure on page 101 of Amendment No. 1 to include disclosure of $430,000 of inventories that, as of the most recent period end (March 31, 2025), did not have material sales during the preceding 12 months. The Company respectfully notes that substantially all of these inventories were implants with sizes that are less commonly used but that are included in the various implant families available to surgeons for use in surgery. The Company further notes that it generated revenue from the sale of more commonly used implants included in such implant families during the period. Statements of Operations, page F-4 3. We have read your response to prior comment 7. We understand from your disclosure on page F-24 that you have chosen to exclude depreciation and amortization expense from your cost of goods sold account balances on pages F-4 and F-16. Consequently, it appears that the guidance in SAB 11:B is applicable. It is not clear whether the absence of parenthetical disclosures, or the existing presentation of gross profit, are appropriate. Further, it appears that your discussion of COGS in MD&A should include a prominent clarification that your reported cost of goods sold balances do not include depreciation and amortization expense. The guidance in Item 10(e)(1) of Regulation S-K may also be applicable. Please revise accordingly or explain. Response: The Company respectfully acknowledges the Staff’s comment and submits to the Staff that the Company interprets the guidance in SAB 11:B to require a particular July 9, 2025 Page 3 presentation, including parenthetical disclosure, when there is depreciation, depletion and amortization attributable to revenue producing activity that is excluded from cost of goods sold. The Company purchases all finished goods from third party suppliers under contract manufacturing arrangements. Since the Company does not manufacture any of its products, it does not own or operate any equipment used in the manufacturing process of its products. Given that the Company does not own any such equipment, the Company believes that cost of goods sold includes all appropriate costs to bring inventory to a salable state and that gross profit is appropriately presented. Further, the Company’s depreciation related to surgical instruments, which comprises the majority of the Company’s depreciation expense (as disclosed on page F-28 in Amendment No. 1), is included in selling, general, and administrative expenses because such instruments are used in the sales process for the Company’s implants and are not considered a performance obligation. Similarly, the Company’s amortization related to its software license is included in selling, general and administrative expenses as the software is used as a marketing tool to prospective customers and not considered a performance obligation. The Company advises the Staff that it does not believe it has excluded depreciation or amortization from cost of goods sold and respectfully submits that it has appropriately classified this expense within selling, general, and administrative expenses based on the nature and use of the underlying long-lived assets, which are not directly associated with satisfying the performance obligation because the customer does not obtain control of the surgical instruments. As the Company believes that its existing presentation of depreciation in selling, general and administrative expenses is appropriate under US GAAP, the Company respectfully submits to the Staff that it believes its existing presentation of gross profit and the absence of related parenthetical disclosures are also appropriate and that it does not believe the relevant guidance in Item 10(e)(1) of Regulation S-K is applicable. ********* July 9, 2025 Page 4 We hope that the foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (714) 755-8051 with any questions or further comments you may have regarding this filing or if you wish to discuss the above. Sincerely, /s/ Ross McAloon Ross McAloon of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) Robert Ball, Chief Executive Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-03 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 July 3, 2025

Robert Ball
Chief Executive Officer
Shoulder Innovations, Inc.
1535 Steele Avenue SW, Suite B
Grand Rapids, MI 49507

 Re: Shoulder Innovations, Inc.
 Amendment No. 2 to Draft Registration Statement on Form S-1
 Submitted June 18, 2025
 CIK No. 0001699350
Dear Robert Ball:

 We have reviewed your amended draft registration statement and have the
following
comments.

 Please respond to this letter by providing the requested information and
either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, any references to prior comments are to
comments in
our June 9, 2025 letter.

Amendment No. 2 to Draft Registration Statement on Form S-1
Reverse Stock Split, page 13

1. As a reminder, please note the guidance in SAB 4:C and SAB 4:D regarding
your
 impending stock split.
 July 3, 2025
Page 2
Critical Accounting Policies and Estimates, page 98

2. We have read your response to prior comment 4. Given the materiality of
your
 inventory balance, please expand your disclosure to quantify the extent
to which the
 asset account includes products for which there were no material sales
during the most
 recent period. Reconcile this data with your conclusion that your March
31, 2025
 inventory reserve is adequate. Your existing disclosure acknowledges the
existence of
 aged inventory but does not provide any context enabling a reader to
gauge their
 significance relative to the corresponding reserves. The risk factor on
page 20 appears
 relevant in this regard. See Item 303(b)(3) of Regulation S-K.
Statements of Operations, page F-4

3. We have read your response to prior comment 7. We understand from your
disclosure
 on page F-24 that you have chosen to exclude depreciation and
amortization expense
 from your cost of goods sold account balances on pages F-4 and F-16.
Consequently,
 it appears that the guidance in SAB 11:B is applicable. It is not clear
whether the
 absence of parenthetical disclosures, or the existing presentation of
gross profit,
 are appropriate. Further, it appears that your discussion of COGS in
MD&A should
 include a prominent clarification that your reported cost of goods sold
balances do not
 include depreciation and amortization expense. The guidance in Item
10(e)(1) of
 Regulation S-K may also be applicable. Please revise accordingly or
explain.

 Please contact Al Pavot at 202-551-3738 or Li Xiao at 202-551-4391 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Ross McAloon, Esq.
</TEXT>
</DOCUMENT>
2025-06-09 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 June 9, 2025

Robert Ball
Chief Executive Officer
Shoulder Innovations, Inc.
1535 Steele Avenue SW, Suite B
Grand Rapids, MI 49507

 Re: Shoulder Innovations, Inc.
 Amendment No. 1 to Draft Registration Statement on Form S-1
 Submitted May 23, 2025
 CIK No. 0001699350
Dear Robert Ball:

 We have reviewed your amended draft registration statement and have the
following
comments. Please respond to this letter by providing the requested information
and either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, any references to prior comments are to
comments in
our May 14, 2025 letter.

Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 2

1. We note your response to comment 1, including your revised disclosure on
page 2
 referencing "publicly available industry data, including from the
National Institutes of
 Health." Please revise to provide the specific source for your estimate
that shoulder
 conditions result in more than eight million physician visits annually
in the United
 States and can require surgical intervention.
2. We note your revised disclosure in response to comment 2, including that
"for the
 three months ended March 31, 2025, [you] estimate an implied utilization
rate for
 [y]our ProVoyance technology of approximately 90% based on the number of
surgical
 plans reported to have been created using ProVoyance technology and the
number of
 [y]our implant systems sold during such period." We also note your
response that
 June 9, 2025
Page 2

 "this information is based on real-world data from [your] customers and
the actual
 number of implant systems sold during the respective period," "[t]he
ProVoyance
 technology tracks and reports each surgical plan it is used to create
[and ba]sed on
 those reports . . . a total of 1,303 surgical plans were created using
ProVoyance during
 the three months ended March 31, 2025," and "[d]uring the same period,
[you] sold
 1,443 implant systems, which, when considered against the 1,303 surgical
plans
 created during the same period, yields an implied utilization rate of
90%." Please
 revise your disclosures on page 3 to include this additional information
provided in
 your response to comment 2.
Market Overview, page 4

3. We note your response to comments 5 and 6, including your revised
disclosure on
 page 4 that, "[b]ased on [y]our internal estimates, knowledge of [y]our
industry and
 third-party data regarding the number of shoulder arthroplasty
procedures performed,
 [you] expect this market to grow by approximately 11% annually through
2029," and
 that "[you] believe a significant opportunity exists outside of the
United States and,
 based on third-party industry reports and [y]our internal estimates,
[you] estimate that
 the total international shoulder arthroplasty market is approximately
$1.7 billion in
 2025." You also disclose that "[t]ogether, [you] believe these markets
represent a
 global annual shoulder arthroplasty market of approximately $3.4
billion." Please
 revise to cite the third-party data and industry reports referenced
above, further
 discuss how these growth and total international market estimates were
calculated,
 and elaborate on any material assumptions underlying such calculations.
Critical Accounting Policies and Estimates, page 96

4. We note that inventories comprise over 20% of total assets and that
inventory
 adjustments adversely impacted your 2024 gross margin. Given that the
March 31,
 2025 inventory balance is 40% higher than your annualized cost of goods
sold
 (COGS), it is not clear whether the asset balance includes a substantial
amount of
 aged inventory. Based on your response to prior comment 12, it is not
clear whether
 you may have a material amount of inventory that has been re-sterilized
upon
 expiration of its five year shelf life. We note that you track the age
of your inventory
 items (page F-20), and that obsolescence and your markets sensitivity to
new products
 and innovation have been identified as material risks on pages 19-31.
Please provide a
 critical accounting policy disclosure that quantifies the extent to
which your inventory
 asset balance includes products for which there were no material sales
during the most
 recent quarter. Disclose the amounts of inventory on hand that you
determined to be
 obsolete or unmarketable. Reconcile this data with your conclusion that
your March
 31, 2025 inventory reserve is adequate. See Item 303(b)(3) of Regulation
S-K.
5. Based on your response to prior comment 12, we understand that you
estimate your
 future twelve month sales levels when determining your non-current
inventory
 amounts. Based on your December 31, 2023 inventory balance and your 2024
COGS
 balance, it appears that this estimate may have been off by 25% at
December 31,
 2023. Similarly, the disparity appears to exceed 45% at December 31,
2022. Further,
 it appears that you are classifying all of your inventory as current
based on an
 expectation that 2025 sales will increase by over 90%. Consequently, it
remains
 June 9, 2025
Page 3

 unclear why you have not classified a portion of your inventory as
non-current. Please
 revise or provide a critical accounting policy disclosure that addresses
the accuracy of
 your prior estimates and quantifies the impact of your 2025 sales growth
estimate on
 your inventory classification. See ASC 210-10-45-3 and Article 303(b)(3)
of
 Regulation S-K.
Competition, page 136

6. We note your response to comment 18, including your revised disclosure
on page 136
 that you "have seen and continue to see consolidation amongst [y]our
competitors and
 have seen and continue to see [y]our competitors innovate and improve
upon
 traditional implants and technologies." Please revise your disclosure in
this section to
 note whether any of your competitors offer specific alternatives to
traditional glenoid
 implants and humeral stem technologies.
Statements of Operations, page F-4

7. Based on the disclosure on page F-27, it does not appear that
depreciation expense is
 included in Cost of Goods Sold. Please clarify for us how your
presentation here and
 on page F-16 complies with SAB 11:B.
Surgical Instruments, page F-21

8. Regarding your response to prior comment 20, please provide an
accounting policy
 disclosure that clarifies the basis for your statement that "the
customers do not obtain
 control of the surgical instruments." In this regard, we understand that
the surgical
 instruments are provided to customers at no cost and that there does not
appear to be
 a legally enforceable contract governing your continuing ownership
rights over these
 instruments. Further, it is not clear whether any material quantity of
non-
 defective surgical instruments has ever been returned to you by your
customers. Also,
 it is not clear whether you have an effective method to objectively
verify the existence
 of these instruments after they are transferred to the customers which
makes the
 application of a substantive impairment policy uncertain. The known
factors you
 considered in assigning the 5 year useful life are similarly not clear.
Given that
 surgical instruments appear to comprise over 15% of your total assets,
please expand
 your disclosure to address these issues.
 Please contact Al Pavot at 202-551-3738 or Li Xiao at 202-551-4391 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Ross McAloon, Esq.
</TEXT>
</DOCUMENT>
2025-05-15 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 14, 2025

Robert Ball
Chief Executive Officer
Shoulder Innovations, Inc.
1535 Steele Avenue SW, Suite B
Grand Rapids, Michigan 49507

 Re: Shoulder Innovations, Inc.
 Draft Registration Statement on Form S-1
 Submitted April 17, 2025
 CIK No. 0001699350
Dear Robert Ball:

 We have reviewed your draft registration statement and have the
following comments.

 Please respond to this letter by providing the requested information and
either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.

Draft Registration Statement on Form S-1 submitted April 17, 2025
Prospectus Summary, page 2

1. We note your statement that certain conditions that can result in
shoulder pain and
 reduce functionality result in more than eight million estimated
physician visits
 annually in the United States. Please provide the source of this
estimate.
2. We note your statement that "for the three months ended March 31, 2025,
nine
 surgical plans were created using ProVoyance for every ten surgical
cases,
 representing an implied utilization rate of 90%." Please revise to
provide greater detail
 of how this data was obtained, including the size, jurisdiction, and
scope of the study,
 as applicable. Please also clarify what you mean by an implied
utilization rate and
 explain the difference, if any, between an implied utilization rate and
a utilization rate
 in this context. If known and to the extent it is materially different,
please also
 May 14, 2025
Page 2

 disclose the percentage of procedures using your advanced implant
systems that also
 used your ProVoyance technology during the applicable period.
3. We refer to your disclosure that you initially launched your InSet
Glenoid product in
 2016, began using ProVoyance in 2021, and launched your initial I-Series
system, the
 InSet 95 Humeral Stem, in 2023 and that you anticipate pursuing FDA
clearance of
 additional I-Series implants, such as the InSet 70, InSet 135 and InSet
185 stems, over
 the next twelve months. You also state on page 48 that your systems
are regulated as
 medical devices in the United States. Please revise your disclosure
in this section to
 clarify the timeline for the development of each of your products since
your inception.
 In your revised disclosure, please also discuss the FDA s
classification of each
 product as a medical device into one of three classes (Class I, Class
II, and Class III)
 depending on its level of risk, specify when you obtained FDA approval
for each
 product, and disclose the current status of development of your InSet
70, InSet 135
 and InSet 185 stem products.
4. We refer to your statements here and elsewhere in the registration
statement that your
 ProVoyance technology is cleared by the FDA for preoperative shoulder
planning on
 the FDA s AI/ML-enabled medical devices list. In an appropriate
section of your
 registration statement, please describe the approval process for the FDA
 s AI/ML-
 enabled medical devices, including any material differences from the FDA
 s
 classification of and approval pathways for medical devices.
Market Overview, page 4

5. We note your statement that the shoulder arthroplasty market in the
United States is
 expected to grow by greater than 10% annually through 2029. Please
revise to provide
 a specific estimated growth rate or a range of estimated growth rates.
Additionally,
 please clarify whether this estimate is provided by a third party or
made by your
 management and provide the basis, source and material assumptions for
such
 estimate, as applicable.
6. Please disclose how the $1.7 billion estimate of the total international
shoulder
 arthroplasty market for 2025 is calculated and discuss any material
assumptions or
 estimates underlying the calculation. To the extent the estimate is
based in part on
 your average sales price in the United States, please note whether any
adjustments
 were made to the average sales price and any potential challenges or
uncertainties
 regarding international sales, such as different reimbursement regimes
or issues
 related to government payors.
Product Liability Claims, page 23

7. In order for readers to better assess this risk, please expand this risk
factor to disclose
 whether product liability claims, lawsuits or recalls have actually
materially impacted
 your business, financial condition or results of operations. As a
related matter, expand
 your financial statement notes to disclose your product warranty term,
as well as any
 material product warranty liabilities in accordance with ASC
460-10-50-8. If not
 material, disclose that fact.
 May 14, 2025
Page 3
Risk Factors
We are and in the future may be subject to claims that we or our employees have
misappropriated the intellectual property..., page 46

8. We note your reference here to certain patents and patent applications
licensed from
 Boston University that were made with financial assistance from the
federal
 government. Please clarify if you license any material intellectual
property rights
 other than pursuant to the software license agreement with Genesis
Software. If so,
 please describe the material terms of the licenses and license
agreements in
 the Intellectual Property section of your prospectus.
Internal Controls, page 59

9. Please expand your disclosure to clarify whether there are any
identified material
 weaknesses in your internal controls.
Use of Proceeds, page 75

10. To the extent known, please revise to disclose the approximate amount of
proceeds
 you intend to allocate toward each of the purposes identified in this
section. Please
 also confirm whether you intend to use the proceeds of the offering
towards the
 development of any specific products, and if so, how much you intend to
allocate and
 how far the proceeds from the offering will allow you to proceed with
such programs,
 as applicable. We note your disclosure on pages 84 and 86 that you
anticipate that you
 will continue to invest significantly in product development and
expect your
 research and development expenses to increase as you pursue
development of new
 products and product enhancements. Refer to Instruction 3 to Item 504
of Regulation
 S-K.
Net Revenue, page 85

11. Please expand your disclosure to address the historical and expected
future impact of
 the downward pricing pressures highlighted on page 24. If the impact has
been
 immaterial, please disclose that information here and on page 24.
Critical Accounting Policies, page 94

12. We note that inventories constitute your largest asset and that
inventory adjustments
 adversely impacted your 2024 gross margin. Given that the December 31,
2024
 inventory balance is almost twice the amount of your annual cost of
goods sold, it is
 not clear whether the asset balance includes a substantial amount of
aged inventory.
 We note that you track the age of your inventory items (page F-9) and
that
 obsolescence has been identified as a material risk (pages 28 and 30).
Please provide a
 critical accounting policy disclosure that quantifies the extent to
which your inventory
 asset balance includes products for which there were no material sales
during the most
 recent quarter. Disclose the amounts of inventory on hand that you
determined to be
 obsolete or unmarketable. Reconcile this data with your conclusion that
the $287K
 inventory reserve at December 31, 2024 is adequate. Explain why none of
your
 inventory has been classified as long-term. See Item 303(b)(3) of
Regulation S-K.
 May 14, 2025
Page 4
Market Dynamics in Shoulder Arthroplasty, page 107

13. We note your statement that "ASCs have emerged as a low-cost site of
care and
 ambulatory-based outcomes have been demonstrated to be positive relative
to
 hospital-based outcomes." Please briefly describe the way
ambulatory-based
 outcomes have been demonstrated to be positive relative to
hospital-based outcomes,
 including any applicable metrics used to measure the relative outcomes.
Independent Distributor Network, page 119

14. We refer to your disclosure here and on pages 20 and 102 that you rely
on an
 independent distributor network comprised of 25 independent distributors
with an
 aggregate of 140 trained agents to sell your implant systems to
hospitals. Please also
 disclose whether you have entered into any agreements with the
distributor network or
 independent distributors, and if so, please provide a brief description
of the material
 terms of any such agreement. If material, please also file such
agreement as an exhibit
 to the registration statement as required by Item 601(b)(10) of
Regulation S-K, or
 explain to us why you believe you are not required to do so.
Clinical Overview, page 120

15. We refer to your disclosure on page 121 that you have contributed to
numerous
 publications since your founding. Please clarify in this section,
including the table
 summarizing the select publications and studies, and in greater detail
elsewhere in the
 registration statement to disclose whether you funded or sponsored the
clinical studies
 and if your employees were involved in both the studies and
publications.
Intellectual Property, page 125

16. We note your statement that the estimated patent expiration dates you
provided
 "should not be relied upon for any purpose." Please remove this
statement as investors
 are entitled to rely on your disclosure.
17. We note your disclosure relating to your eleven issued U.S. patents,
seven issued
 foreign patents, twelve pending U.S. non-provisional patent applications
and
 seventeen pending foreign patent applications. Please expand your
tabular disclosure
 to include each material pending patent application. For each material
patent or patent
 application, please revise to include a more detailed description of the
scope and
 technology for each patent or patent application, the type of patent
protection
 (composition of matter, use, or process), and expiration dates. We also
note that
 twelve issued U.S. patents are listed in the tabular disclosure of your
owned patents.
 Please reconcile your disclosure accordingly.
Competition, page 129

18. We note your disclosure throughout the registration statement that you
currently offer
 highly differentiated shoulder implant systems for shoulder
arthroplasty. We also
 refer to your disclosure here and on page 19 that you compete with
large,
 multinational companies and smaller orthopedic companies, such as
Arthrex, Enovis,
 Exectech, Johnson & Johnson, Smith & Nephew, Stryker, and Zimmer Biomet.
Please
 revise your disclosure in this section to clarify whether any of your
competitors also
 May 14, 2025
Page 5

 offer alternatives to traditional glenoid implants and humeral stem
technologies.
Legal Proceedings, page 139

19. To the extent material, please provide a description of the factual
basis alleged to
 underlie the counterclaim filed by Catalyst and the relief sought in the
counterclaim.
 Please refer to Item 103(a) of Regulation S-K.
Statements of Operations, page F-5

20. Based on your disclosures in Note 12, it appears that the cost of goods
sold line item
 excludes depreciation and amortization expense. Please revise your
presentation
 consistent with the guidance in SAB 11:B. You also disclosed in Note 1
that you
 reclassified depreciation expense on surgical instruments from cost of
goods sold to
 selling, general and administrative expense for 2023 and since. Expand
your
 disclosure to discuss your operating and sales process involving
surgical instruments,
 including whether they are sold separately or in combination with your
implant
 systems, or if they are distributed for free to surgeons and hospitals.
Explain to us
 your consideration for their impact in revenue recognition, as well as
your basis for
 reclassifying them from cost of goods sold. In that regard, we note
instruments
 account as your largest property and equipment item as shown in Note 4.
Revenue Recognition, page F-11

21. You disclose that in addition to your advanced implant system, your
ecosystem is also
 comprised of ProVoyance preoperative planning technology, efficient
instrument
 system, specialized support and surgeon-to-surgeon collaboration.
Explain to us, and
 revise if necessary, whether any of these other components constitutes
an additional
 performance obligation under ASC 606.
General

22. Please provide us with supplemental copies of all written
communications, as defined
 in Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your
 behalf, present to potential investors in reliance on Section 5(d) of
the Securities Act,
 whether or not they retain copies of the communications. Please contact
legal staff
 associated with the review of this filing to discuss how to submit the
materials, if any,
 to us for review.
 May 14, 2025
Page 6

 Please contact Al Pavot at 202-551-3738 or Li Xiao at 202-551-4391 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Conlon Danberg at 202-551-4466 or Jane Park at 202-551-7439 with any other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Ross McAloon, Esq.
</TEXT>
</DOCUMENT>