# Stryker Corp.

- Location (FDA's records): Kalamazoo, MI
- FDA decisions: 354 (1976–2026): 352 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Stryker Corp. (125); Stryker (92); Stryker Corporation (82); Stryker GmbH (55)
- Product codes: HRS (25), GCJ (20), MAX (17), JEY (13), HSB (12), HRX (12), KTT (11), MBI (10), GWO (10), NKB (10), OLO (9), GEI (9)
- 510(k) review time since 2016: median 98 days, against 108 for FDA's reviews in the same codes and years (87 of 146 faster)
- Predicates its devices cite: 613 (199 its own); citations of its devices by later devices: 649 (199 its own)
- Recalls linked to its devices: 219 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 61 (https://510kreport.com/company/howmedica-osteonics)
- Stryker Spine: 58 (https://510kreport.com/company/stryker-spine)
- Stryker Instruments: 21 (https://510kreport.com/company/stryker-instruments)
- Stryker Endoscopy: 17 (https://510kreport.com/company/stryker-endoscopy)
- Stryker Trauma AG: 17 (https://510kreport.com/company/stryker-trauma)
- Synthes (Usa): 13 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 11 (https://510kreport.com/company/smith-nephew)
- Synthes Spine: 8 (https://510kreport.com/company/synthes-spine)

## Firms that cite its devices most
- Stryker Spine: 40 (https://510kreport.com/company/stryker-spine)
- Stryker Instruments: 33 (https://510kreport.com/company/stryker-instruments)
- Stryker Endoscopy: 19 (https://510kreport.com/company/stryker-endoscopy)
- Stryker Leibinger GmbH & Co KG: 15 (https://510kreport.com/company/stryker-leibinger)
- L&K BIOMED Co., Ltd.: 12 (https://510kreport.com/company/l-k-biomed)
- K2m, Inc.: 12 (https://510kreport.com/company/k2m)
- Globus Medical, Inc.: 7 (https://510kreport.com/company/globus-medical)
- Stryker Neurovascular: 6 (https://510kreport.com/company/stryker-neurovascular)

## Its most-cited devices
- K032945: Simplex X (2004), cited by 15
- K083661: Avs TL Peek Spacers (2009), cited by 15
- K093704: Avs PL Peek Spacers (2009), cited by 13
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (2015), cited by 12
- K142381: Xia 3 Spinal System (2014), cited by 12
- K082014: Stryker Spine Avs PL Peek Spacers (2008), cited by 12

## Recent decisions
- K261481: Pangea Femur Reconstruction System (Jun 29, 2026)
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (Feb 3, 2026)
- K253202: Hoffmann LRF System (Dec 19, 2025)
- K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (Aug 20, 2025)
- K250163: T2 Alpha Femur Retrograde Nailing System (Aug 13, 2025)
- K242445: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (Oct 6, 2024)
- K233919: VariAx 2 Distal Radius System (Mar 25, 2024)
- K233741: Hoffmann LRF System (Dec 21, 2023)

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