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 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.
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