# Tornier, Inc. (manufacturer, Bloomington, MN): 1 new FDA device listing, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Tornier, Inc. |
| Owner / operator | Stryker Corp. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Bloomington, MN, US |
| New listings | 1 |
| Devices | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Product codes | KWS |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Tornier Perform Advanced Glenoid |
| First new listing | 2026-09-30 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 1649390 |
| 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.
- 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: 2026-11-04T21:52:36.524Z.
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.