# Howmedica Osteonics Corp., Dba Stryker Orthopaedics

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 34 (2010–2026): 34 510(k) clearances
- Names in FDA's records: Howmedica Osteonics Corp., Dba Stryker Orthopaedics (31); Howmedica Osteonics Corp (Dba Stryker Orthopaedics) (1); Howmedica Osteonics, Dba Stryker Orthopaedics (1); Howmedica Osteonics Corp. dba Stryker Orthopaedics (1)
- Product codes: LPH (6), HRS (5), KRO (5), JDI (4), JWH (4), LZO (3), MBH (2), KKY (1), KRR (1), KWL (1), JDQ (1), LZN (1)
- 510(k) review time since 2016: median 69 days, against 111 for FDA's reviews in the same codes and years (13 of 23 faster)
- Predicates its devices cite: 164 (31 its own); citations of its devices by later devices: 51 (31 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 57 (https://510kreport.com/company/howmedica-osteonics)
- Stryker Orthopaedics: 22 (https://510kreport.com/company/stryker-orthopaedics)
- Osteonics Corp.: 15 (https://510kreport.com/company/osteonics)
- Howmedica Corp.: 9 (https://510kreport.com/company/howmedica)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics: 8 (https://510kreport.com/company/howmedica-osteonics-aka-stryker-orthopaedics)
- Stryker Corp.: 5 (https://510kreport.com/company/stryker)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Stryker Leibinger GmbH & Co KG: 2 (https://510kreport.com/company/stryker-leibinger)

## Firms that cite its devices most
- Stryker Corp.: 5 (https://510kreport.com/company/stryker)
- Stryker Trauma AG: 5 (https://510kreport.com/company/stryker-trauma)
- Flower Orthopedics Corporation: 2 (https://510kreport.com/company/flower-orthopedics)
- United Orthopedic Corporation: 1 (https://510kreport.com/company/united-orthopedic)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics: 1 (https://510kreport.com/company/howmedica-osteonics-aka-stryker-orthopaedics)
- Howmedica Osteonics Corp. Dba Stryker Orthopeadics: 1 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopeadics)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)

## Its most-cited devices
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), cited by 4
- K202016: Dall-Miles® Cable System (2020), cited by 4
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), cited by 4
- K222056: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (2023), cited by 3
- K242831: Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System (2024), cited by 3
- K223528: Triathlon® Hinge Knee System (2023), cited by 3

## Recent decisions
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (Aug 6, 2026)
- K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (Jul 10, 2026)
- K253637: Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (Feb 18, 2026)
- K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (Dec 15, 2025)
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (Oct 24, 2025)
- K251665: Triathlon® Hinge Knee System (Jul 25, 2025)
- K250989: Stryker and Serf hip devices (Jul 25, 2025)
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (Feb 6, 2025)

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