# Stryker Instruments

- Location (FDA's records): Kalamazoo, MI
- FDA decisions: 77 (1994–2026): 77 510(k) clearances
- Product codes: GEI (8), HAW (6), FYA (5), JEY (5), FRN (4), GXP (3), GXI (3), NDN (2), LFL (2), FQH (2), HBE (2), NKB (2)
- 510(k) review time since 2016: median 93 days, against 122 for FDA's reviews in the same codes and years (13 of 18 faster)
- Predicates its devices cite: 130 (23 its own); citations of its devices by later devices: 113 (23 its own)
- Recalls linked to its devices: 244 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Corp.: 33 (https://510kreport.com/company/stryker)
- Stryker Leibinger GmbH & Co KG: 6 (https://510kreport.com/company/stryker-leibinger)
- Walter Lorenz Surgical, Inc.: 6 (https://510kreport.com/company/walter-lorenz-surgical)
- Surgical Dynamics, Inc.: 6 (https://510kreport.com/company/surgical-dynamics)
- Baylis Medical Co., Inc.: 4 (https://510kreport.com/company/baylis-medical)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Dyonics, Inc.: 4 (https://510kreport.com/company/dyonics)
- Merit Medical Systems, Inc.: 3 (https://510kreport.com/company/merit-medical-systems)

## Firms that cite its devices most
- Stryker Corp.: 21 (https://510kreport.com/company/stryker)
- Stryker Leibinger GmbH & Co KG: 5 (https://510kreport.com/company/stryker-leibinger)
- Stryker Instruments, Instruments Div.: 3 (https://510kreport.com/company/stryker-instruments-instruments-div)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- Osteomed LP: 3 (https://510kreport.com/company/osteomed)
- Bioplate, Inc.: 2 (https://510kreport.com/company/bioplate)
- Tekka: 2 (https://510kreport.com/company/tekka)
- Relievant Medsystems: 2 (https://510kreport.com/company/relievant-medsystems)

## Its most-cited devices
- K022185: Universal CMF System (2002), cited by 12
- K022365: Stryker Navigation System - Hip Module (2003), cited by 7
- K991696: Stryker Hermes-Ready Total Performance System (1999), cited by 6
- K043334: Bone Source Hac Rapid Setting Cement (2005), cited by 5
- K014263: Newgen/Universal Mandibular System (2002), cited by 5
- K032473: Dekompressor Percutaneous Discectomy Probe (2003), cited by 5

## Recent decisions
- K262386: SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (Oct 20, 2026)
- K262244: Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328) (Oct 8, 2026)
- K261959: Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) (Sep 17, 2026)
- K261544: Hydro Irrigation System (Jun 17, 2026)
- K253679: Hydro Irrigation System (May 8, 2026)
- K252282: SurgiCount+ System (Mar 16, 2026)
- K251971: RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (Sep 25, 2025)
- K250483: PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (Sep 9, 2025)

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