# Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 11 (2016–2023): 11 510(k) clearances
- Names in FDA's records: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (9); Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) (2)
- Product codes: LPH (6), HSX (2), MBH (2), JDI (1)
- 510(k) review time since 2016: median 120 days, against 157 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 34 (3 its own); citations of its devices by later devices: 18 (3 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 16 (https://510kreport.com/company/howmedica-osteonics)
- Stryker Orthopaedics: 8 (https://510kreport.com/company/stryker-orthopaedics)
- Osteonics Corp.: 4 (https://510kreport.com/company/osteonics)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics: 1 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopaedics)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Mako Surgical Corp.: 1 (https://510kreport.com/company/mako-surgical)

## Firms that cite its devices most
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics: 8 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopaedics)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Mako Surgical Corp.: 1 (https://510kreport.com/company/mako-surgical)
- Stryker Orthopaedics (Aka Howmedica Osteonics Corp.): 1 (https://510kreport.com/company/stryker-orthopaedics-aka-howmedica-osteonics)
- Stryker Orthopaedics: 1 (https://510kreport.com/company/stryker-orthopaedics)

## Its most-cited devices
- K172634: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (2017), cited by 4
- K171768: Trident® II Acetabular System (2017), cited by 3
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), cited by 3
- K180612: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (2018), cited by 2
- K191358: Trident II Acetabular System (2019), cited by 2
- K203099: Triathlon PKR System (2020), cited by 1

## Recent decisions
- K233261: Global Modular Replacement System (Dec 8, 2023)
- K210893: Restoration Anatomic Shell (Apr 22, 2021)
- K203099: Triathlon PKR System (Oct 27, 2020)
- K193233: Restoration® Modular Hip System (May 27, 2020)
- K191358: Trident II Acetabular System (Oct 24, 2019)
- K190991: Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment (Aug 15, 2019)
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (Mar 19, 2019)
- K180612: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (Jun 7, 2018)

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