Data / Medical devices / United States / SHOULDER INNOVATIONS, Inc
SHOULDER INNOVATIONS, Inc: FDA-registered device maker in Grand Rapids, MI, United States, 11 510(k) clearances
SHOULDER INNOVATIONS, Inc is registered with the FDA (registration 3012544635) in Grand Rapids, MI, United States. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012544635
- Address
- 1535 Steele Ave SW Suite B, Grand Rapids, MI, United States, 49507
- Owner or operator
- Shoulder Innovations, Inc (10051976)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 26, 2016
- Registered through
- 2027
- Brand names listed
- Humeral Short Stem System, InSet Reverse Total Shoulder System, InSet Total Shoulder System, Inset Reverse Total Shoulder System, N22 EZ Glenosphere, N22 Offset Humeral Head, Shoulder Innovations Total Shoulder Replacement System, Shoulder Innovations Total Shoulder System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | 2 | Specification developer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K262173 | N22 Offset Humeral Head | KWT | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| April 13, 2026 | K254128 | InSet Reverse Total Shoulder System | PHX | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| January 15, 2026 | K252516 | N22 EZ Glenosphere | PHX | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| February 11, 2025 | K241817 | InSet Total Shoulder System | KWT | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| March 11, 2022 | K213615 | Shoulder Innovations Total Shoulder System | PKC | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| August 20, 2021 | K210533 | Inset Reverse Total Shoulder System | PHX | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| November 29, 2019 | K192365 | Shoulder Innovations Total Shoulder System | KWT | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| October 23, 2018 | K173824 | Humeral Short Stem System | MBF | Substantially Equivalent | Shoulder Innovations, Inc. | accessdata.fda.gov |
| July 5, 2011 | K111596 | TOTAL SHOULDER SYSTEM | KWS | Substantially Equivalent | Shoulder Innovations, LLC | accessdata.fda.gov |
| May 24, 2011 | K110905 | TOTAL SHOULDER SYSTEM | KWS | Substantially Equivalent | Shoulder Innovations, LLC | accessdata.fda.gov |
| January 24, 2011 | K102670 | TOTAL SHOULDER SYSTEM | KWS | Substantially Equivalent | Shoulder Innovations, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.