# EDGAR Filing Document

**Accession Number:** 0001699350
**File Stem:** 0000000000-25-006055
**Filing Date:** 2025-6
**Character Count:** 9980
**Document Hash:** c3e3f74defd76cedef8a7741c38a04a3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-25-006055.hdr.sgml**: 20250923

**ACCESSION NUMBER**: 0000000000-25-006055

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20250609

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** SHOULDER INNOVATIONS, INC.
- **CENTRAL INDEX KEY:** 0001699350
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 270538764
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD
- **SEC FILE NUMBER:** 377-07913

**BUSINESS ADDRESS:**
- **STREET 1:** 13827 PORT SHELDON STREET
- **CITY:** HOLLAND
- **STATE:** MI
- **ZIP:** 49424
- **BUSINESS PHONE:** 616-566-0286

**MAIL ADDRESS:**
- **STREET 1:** 13827 PORT SHELDON STREET
- **CITY:** HOLLAND
- **STATE:** MI
- **ZIP:** 49424
**PUBLIC REFERENCE ACCESSION NUMBER**: 0001628279-25-000227

## Text-Extract

```

                                                            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.

```

### Attached PDF Documents

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