Chrysalis Intelligence · Sponsors · Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Mahwah, NJ, US · 26 510(k) clearances

Total clearances
26
2020-07-10 → 2026-08-06
Last 12 months
5
Product codes
9
Most recent
2026-08-06
Name variants in FDA filings: Howmedica Osteonics Corp., Dba Stryker Orthopaedics / Howmedica Osteonics Corp. dba Stryker Orthopaedics
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KRO 5 2026-08-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II Orthopedic 5 2026-07-10
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II Orthopedic 4 2025-02-06
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class II Orthopedic 4 2024-08-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class II Orthopedic 3 2024-04-24
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class II Orthopedic 2 2026-02-18
KWL 1 2022-10-21
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class II Orthopedic 1 2021-06-04
JDQ 1 2020-10-16
Filings

All 510(k) clearances (26)

Date K-number Device Code Class Specialty
2026-08-06 K261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System KRO
2026-07-10 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 LPH Class II Orthopedic
2026-02-18 K253637 Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert MBH Class II Orthopedic
2025-12-15 K252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper KRO
2025-10-24 K252044 Triathlon® Total Knee System - Triathlon® Gold Femoral Components MBH Class II Orthopedic
2025-07-25 K251665 Triathlon® Hinge Knee System KRO
2025-02-06 K243817 Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert JWH Class II Orthopedic
2025-02-06 K243784 Stryker Orthopaedics Hip Devices Labeling Update LPH Class II Orthopedic
2024-12-04 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 JWH Class II Orthopedic
2024-08-02 K241716 Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component JDI Class II Orthopedic
2024-04-24 K234025 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads LZO Class II Orthopedic
2024-04-12 K240418 Stryker Orthopaedics Hip Systems Labeling Update JDI Class II Orthopedic
2024-03-11 K233724 28mm/38D MDM X3 Insert for MDM Liner LZO Class II Orthopedic
2023-12-21 K233498 Stryker Orthopaedics Hip Systems Labeling Update LPH Class II Orthopedic
2023-06-02 K230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component JWH Class II Orthopedic
2023-04-21 K223069 Modular Rotating Hinge Knee Systems and Compatible Components KRO
2023-01-26 K222056 Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee JDI Class II Orthopedic
2023-01-20 K223528 Triathlon® Hinge Knee System KRO
2022-10-21 K222632 UHR Bipolar Implants, Restoration GAP II Implants KWL
2022-03-09 K220376 Acetabular Dome Hole Plug LPH Class II Orthopedic
2022-03-01 K212187 Restoration® Modular Hip System LPH Class II Orthopedic
2022-02-01 K213701 Exeter® X3® RimFit® Cup JDI Class II Orthopedic
2021-12-21 K213129 Restoration Modular 115mm Conical Distal Stem LZO Class II Orthopedic
2021-06-04 K211303 Avon Patello-femoral Joint Prosthesis KRR Class II Orthopedic
2020-10-16 K202016 Dall-Miles® Cable System JDQ
2020-07-10 K201343 Triathlon Total KneeSystem JWH Class II Orthopedic