# Stryker Leibinger GmbH & Co KG

- Location (FDA's records): Kalamazoo, MI
- FDA decisions: 36 (1999–2026): 35 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Stryker Leibinger GmbH & Co KG (23); Stryker Leibinger (12); Stryker Leibinger GmbH (1)
- Product codes: OLO (10), HRS (6), JEY (4), HAW (2), GEI (2), FWP (2), NQR (1), GWO (1), IXI (1), IYE (1), HBW (1), GXP (1)
- 510(k) review time since 2016: median 90 days, against 90 for FDA's reviews in the same codes and years (6 of 13 faster)
- Predicates its devices cite: 59 (16 its own); citations of its devices by later devices: 74 (16 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Corp.: 15 (https://510kreport.com/company/stryker)
- Stryker Instruments: 5 (https://510kreport.com/company/stryker-instruments)
- Howmedica Corp.: 3 (https://510kreport.com/company/howmedica)
- Stryker Corporate: 2 (https://510kreport.com/company/stryker-corporate)
- Stryker Leibinger Micro Implants: 2 (https://510kreport.com/company/stryker-leibinger-micro-implants)
- Osteogenics, Inc.: 2 (https://510kreport.com/company/osteogenics)
- Mako Surgical Corp.: 1 (https://510kreport.com/company/mako-surgical)
- Stingray Surgical Products, Inc.: 1 (https://510kreport.com/company/stingray-surgical-products)

## Firms that cite its devices most
- Stryker Corp.: 7 (https://510kreport.com/company/stryker)
- Stryker Instruments: 6 (https://510kreport.com/company/stryker-instruments)
- Stryker Corporate: 4 (https://510kreport.com/company/stryker-corporate)
- Osteomed LP: 4 (https://510kreport.com/company/osteomed)
- Medartis AG: 3 (https://510kreport.com/company/medartis)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- KLS-Martin L.P.: 3 (https://510kreport.com/company/kls-martin)
- K2m, Inc.: 2 (https://510kreport.com/company/k2m)

## Its most-cited devices
- K040022: Stryker Leibinger Universal Distal Radius System (2004), cited by 12
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy (2001), cited by 10
- K000348: Colorado Microdissection Needle (2000), cited by 5
- K162341: Stryker OrthoMap Precision Knee system (2016), cited by 4
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), cited by 4
- K043250: Stryker Patient Specific Polymer Implant (2005), cited by 4

## Recent decisions
- K261054: RibPlate System (Jul 1, 2026)
- K254233: MEDPOR Customized Implant Kit (Mar 12, 2026)
- K253623: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (Feb 19, 2026)
- K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (Feb 6, 2026)
- K243491: SternalPlate Expansion (Dec 11, 2024)
- K241517: Q Guidance System; Mako Spine System; (Aug 27, 2024)
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (Jul 25, 2024)
- K240651: MRI Universal (Jul 12, 2024)

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