# Tornier, Inc.

- Location (FDA's records): Bloomington, MN
- FDA decisions: 116 (1995–2026): 115 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Tornier, Inc. (52); Tornier (44); Tornier S.A.S. (20)
- Product codes: KWS (32), PHX (25), JDB (9), MBI (7), HSB (4), HSN (4), HRS (4), JWH (3), FTL (3), HSD (3), JDI (2), PKC (2)
- 510(k) review time since 2016: median 140 days, against 132 for FDA's reviews in the same codes and years (12 of 23 faster)
- Predicates its devices cite: 380 (224 its own); citations of its devices by later devices: 365 (224 its own)
- Recalls linked to its devices: 56 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy, Inc.: 15 (https://510kreport.com/company/depuy)
- Zimmer, Inc.: 13 (https://510kreport.com/company/zimmer)
- DePuy Orthopaedics, Inc.: 13 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet, Inc.: 11 (https://510kreport.com/company/biomet)
- Synthes (Usa): 9 (https://510kreport.com/company/synthes-usa)
- Wrightmedicaltechnologyinc: 8 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Encore Medical L.P.: 7 (https://510kreport.com/company/encore-medical)
- Howmedica Osteonics Corp.: 7 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- Exactech, Inc.: 17 (https://510kreport.com/company/exactech)
- Lima Corporate S.P.A.: 14 (https://510kreport.com/company/lima-corporate)
- Stryker Corporation (Tornier, Inc.): 9 (https://510kreport.com/company/stryker-tornier)
- Medacta International S.A.: 9 (https://510kreport.com/company/medacta-international)
- Smith & Nephew, Inc.: 8 (https://510kreport.com/company/smith-nephew)
- Encore Medical L.P.: 8 (https://510kreport.com/company/encore-medical)
- Zimmer, Inc.: 7 (https://510kreport.com/company/zimmer)
- Depuy (Ireland): 6 (https://510kreport.com/company/depuy-ireland)

## Its most-cited devices
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (2016), cited by 21
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications (1995), cited by 19
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), cited by 17
- K122698: Aequalis Ascend Flex Shoulder System (2013), cited by 16
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), cited by 13
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System (2006), cited by 12

## Recent decisions
- K260721: Tornier Perform Advanced Glenoid (Jul 22, 2026)
- K252788: Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (Jan 8, 2026)
- K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max) (Oct 30, 2025)
- K232265: BLUEPRINT™ Patient Specific Instrumentation (Feb 21, 2024)
- K230352: Tornier Humeral Nail and Tornier Long Humeral Nail (Oct 31, 2023)
- K222510: Blueprint Mixed Reality system (Jan 20, 2023)
- DEN220012: Tornier Pyrocarbon Humeral Head (Dec 16, 2022)
- K220914: Tornier Perform Humeral System – Fracture (Oct 14, 2022)

Source page: https://510kreport.com/company/tornier