# Stryker Trauma AG

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 32 (2013–2020): 32 510(k) clearances
- Names in FDA's records: Stryker Trauma AG (25); Stryker Trauma GmbH (7)
- Product codes: HRS (16), HSB (7), KTT (3), HWC (3), HTY (2), KWS (1)
- 510(k) review time since 2016: median 106 days, against 127 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 82 (15 its own); citations of its devices by later devices: 59 (15 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 27 (https://510kreport.com/company/howmedica-osteonics)
- Synthes (Usa): 17 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 5 (https://510kreport.com/company/smith-nephew)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics: 5 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopaedics)
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- Osteonics Corp.: 2 (https://510kreport.com/company/osteonics)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- Stryker Corp.: 17 (https://510kreport.com/company/stryker)
- Globus Medical, Inc.: 5 (https://510kreport.com/company/globus-medical)
- Jeil Medical Corporation: 3 (https://510kreport.com/company/jeil-medical)
- Neoortho Produtos Ortopedicos S/A: 2 (https://510kreport.com/company/neoortho-produtos-ortopedicos-s-a)
- I.T.S. GmbH: 2 (https://510kreport.com/company/its)
- Biedermann Medtech, Inc.: 2 (https://510kreport.com/company/biedermann-medtech)
- Biopro, Inc.: 2 (https://510kreport.com/company/biopro)
- Miami Device Solutions, LLC: 2 (https://510kreport.com/company/miami-device-solutions)

## Its most-cited devices
- K200869: Gamma3 System (2020), cited by 6
- K140769: Variax 2 System (2014), cited by 4
- K132502: Variax 2 System (2013), cited by 4
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (2019), cited by 3
- K130009: Variax 2 Compression Plating System (2013), cited by 3
- K131365: T2 Tibial Nailing System (2013), cited by 3

## Recent decisions
- K200869: Gamma3 System (Jul 22, 2020)
- K193308: T2 Alpha Tibia Nailing System, IMN Screws System (Feb 23, 2020)
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (Jun 11, 2019)
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (Jun 6, 2018)
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (Jan 12, 2018)
- K172210: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (Oct 2, 2017)
- K170418: Stryker SonicPin System (Jun 20, 2017)
- K153154: Asnis JFX System (Dec 28, 2015)

Source page: https://510kreport.com/company/stryker-trauma