# SHOULDER INNOVATIONS, Inc (specification developer, Grand Rapids, MI): 7 new FDA device listings, incl. prosthesis, shoulder, non-constrained, metal/polymer cemented

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | SHOULDER INNOVATIONS, Inc |
| Owner / operator | Shoulder Innovations, Inc |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Grand Rapids, MI, US |
| New listings | 7 |
| Devices | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Shoulder Prosthesis, Reverse Configuration |
| Product codes | KWT, HSD, KWS, MBF, PHX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | N22 Offset Humeral Head; InSet Reverse Total Shoulder System; N22 EZ Glenosphere |
| First new listing | 2026-10-15 |
| Latest new listing | 2026-10-15 |
| FDA registration number | 3012544635 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.