# Stryker Orthopaedics

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 24 (2004–2021): 24 510(k) clearances
- Product codes: LPH (6), MBH (5), LZO (4), MEH (2), JWH (2), HRS (1), JDG (1), LOD (1), HSD (1), JDI (1)
- 510(k) review time since 2016: median 82 days, against 104 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 160 (19 its own); citations of its devices by later devices: 82 (19 its own)
- Recalls linked to its devices: 42 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 102 (https://510kreport.com/company/howmedica-osteonics)
- Osteonics Corp.: 14 (https://510kreport.com/company/osteonics)
- Howmedica Corp.: 6 (https://510kreport.com/company/howmedica)
- Stryker Corp.: 5 (https://510kreport.com/company/stryker)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet, Inc.: 3 (https://510kreport.com/company/biomet)
- Mako Surgical Corp.: 2 (https://510kreport.com/company/mako-surgical)
- Depuy (Ireland): 1 (https://510kreport.com/company/depuy-ireland)

## Firms that cite its devices most
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics: 22 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopaedics)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics: 8 (https://510kreport.com/company/howmedica-osteonics-aka-stryker-orthopaedics)
- Howmedica Osteonics Corp.: 5 (https://510kreport.com/company/howmedica-osteonics)
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- Corentec Co., Ltd.: 3 (https://510kreport.com/company/corentec)
- Stryker Orthopaedics (Aka Howmedica Osteonics Corp.): 3 (https://510kreport.com/company/stryker-orthopaedics-aka-howmedica-osteonics)
- Optimotion Implants, LLC: 2 (https://510kreport.com/company/optimotion-implants)
- Depuy Ireland UC: 2 (https://510kreport.com/company/depuy-ireland-uc)

## Its most-cited devices
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), cited by 14
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), cited by 13
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), cited by 8
- K053514: Triathlon Total Knee System (2006), cited by 7
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), cited by 7
- K143393: Triathlon Tritanium Cone Augments (2015), cited by 6

## Recent decisions
- K211703: Insignia Hip Stem (Aug 16, 2021)
- K191414: EXETER Centralizer, EXETER 2.5mm Plug (Aug 28, 2019)
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (Mar 19, 2018)
- K173849: Triathlon Total Knee System (Feb 2, 2018)
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (Oct 30, 2017)
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (May 25, 2016)
- K151264: Restoration Anatomic Shell (Aug 10, 2015)
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (Feb 9, 2015)

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