# Shoulder Innovations, Inc.

- Location (FDA's records): Grand Rapids, MI
- FDA decisions: 12 (2011–2026): 12 510(k) clearances
- Names in FDA's records: Shoulder Innovations, Inc. (9); Shoulder Innovations, LLC (3)
- Product codes: PHX (4), KWS (3), KWT (3), MBF (1), PKC (1)
- 510(k) review time since 2016: median 116 days, against 130 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 24 (9 its own); citations of its devices by later devices: 11 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet Manufacturing Corp: 6 (https://510kreport.com/company/biomet-manufacturing)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Tornier, Inc.: 2 (https://510kreport.com/company/tornier)
- Depuy Ireland UC: 2 (https://510kreport.com/company/depuy-ireland-uc)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Ignite Orthopedics, LLC: 1 (https://510kreport.com/company/ignite-orthopedics)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)

## Its most-cited devices
- K102670: Total Shoulder System (2011), cited by 3
- K111596: Total Shoulder System (2011), cited by 2
- K210533: Inset Reverse Total Shoulder System (2021), cited by 2
- K173824: Humeral Short Stem System (2018), cited by 1
- K192365: Shoulder Innovations Total Shoulder System (2019), cited by 1
- K252221: Inset Reverse Total Shoulder System (2025), cited by 1

## Recent decisions
- K262173: N22 Offset Humeral Head (Sep 8, 2026)
- K254128: InSet Reverse Total Shoulder System (Apr 13, 2026)
- K252516: N22 EZ Glenosphere (Jan 15, 2026)
- K252221: Inset Reverse Total Shoulder System (Sep 26, 2025)
- K241817: InSet Total Shoulder System (Feb 11, 2025)
- K213615: Shoulder Innovations Total Shoulder System (Mar 11, 2022)
- K210533: Inset Reverse Total Shoulder System (Aug 20, 2021)
- K192365: Shoulder Innovations Total Shoulder System (Nov 29, 2019)

Source page: https://510kreport.com/company/shoulder-innovations