Shoulder Innovations, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Shoulder Innovations, Inc.” (first 2011, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Since 2017 the median was 116 days, against 138 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 309 |
| 2019 | 1 | 91 |
| 2020 | 0 | — |
| 2021 | 1 | 177 |
| 2022 | 1 | 116 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 152 |
| 2026 | 3 | 112 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shoulder Innovations, Inc. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 4 | 4 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 3 | 3 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 3 | 3 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 1 | 1 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Shoulder Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262173 | N22 Offset Humeral Head | KWT | 2026-09-08 | 74 |
| K254128 | InSet Reverse Total Shoulder System | PHX | 2026-04-13 | 112 |
| K252516 | N22 EZ Glenosphere | PHX | 2026-01-15 | 157 |
| K252221 | Inset Reverse Total Shoulder System | PHX | 2025-09-26 | 72 |
| K241817 | InSet Total Shoulder System | KWT | 2025-02-11 | 232 |
| K213615 | Shoulder Innovations Total Shoulder System | PKC | 2022-03-11 | 116 |
| K210533 | Inset Reverse Total Shoulder System | PHX | 2021-08-20 | 177 |
| K192365 | Shoulder Innovations Total Shoulder System | KWT | 2019-11-29 | 91 |
| K173824 | Humeral Short Stem System | MBF | 2018-10-23 | 309 |
| K111596 | TOTAL SHOULDER SYSTEM | KWS | 2011-07-05 | 27 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shoulder Innovations, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
SHOULDER INNOVATIONS, INC. (SI): EDGAR filings, CIK 1699350. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shoulder Options, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shoulder Innovations, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Shoulder Innovations, Inc.” (first 2011, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shoulder Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shoulder Innovations, Inc. is 114 days. Since 2017: 116 days, versus 138 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shoulder Innovations, Inc.?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 4); KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 3); KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, 3).
Next steps
- See all 12 Shoulder Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PHX, Shoulder Innovations, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.