Medical Device Manufacturer · US , Malwah , NJ

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

31 submissions · 31 cleared · Since 2010
31
Total
31
Cleared
0
Denied

Howmedica Osteonics Corp., Dba Stryker Orthopaedics — FDA 510(k) Submissions

Howmedica Osteonics Corp., Dba Stryker Orthopaedics has submitted 31 FDA 510(k) premarket notifications since 2010, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Plate, Fixation, Bone, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
Triathlon? Total Knee System - Triathlon? X3? Medial Stabilized Tibial Bearing Insert
K253637 · MBH Prosthesis, Knee,... · Orthopedic
Feb 2026 91d
Triathlon? Tritanium? Asymmetric Patella; Triathlon? Tritanium? Symmetric Patella; Triathlon? Symmetric Patella; Triathlon? Asymmetric Patella; Scorpio? Universal Dome Patella; Triathlon? Hinge Bumper
K252898 · KRO Prosthesis, Knee,... · Orthopedic
Dec 2025 95d
Triathlon? Total Knee System - Triathlon? Gold Femoral Components
K252044 · MBH Prosthesis, Knee,... · Orthopedic
Oct 2025 116d
Stryker and Serf hip devices
K250989 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2025 116d
Triathlon? Hinge Knee System
K251665 · KRO Prosthesis, Knee,... · Orthopedic
Jul 2025 56d
Stryker Orthopaedics Hip Devices Labeling Update
K243784 · LPH Prosthesis, Hip,... · Orthopedic
Feb 2025 59d
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
K243817 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2025 56d
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
K242831 · JWH Prosthesis, Knee,... · Orthopedic
Dec 2024 76d
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
K241716 · JDI Prosthesis, Hip,... · Orthopedic
Aug 2024 49d
22.2mm BIOLOX? delta Ceramic V40? Femoral Heads
K234025 · LZO Prosthesis, Hip,... · Orthopedic
Apr 2024 126d
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · JDI Prosthesis, Hip,... · Orthopedic
Apr 2024 59d
28mm/38D MDM X3 Insert for MDM Liner
K233724 · LZO Prosthesis, Hip,... · Orthopedic
Mar 2024 111d
Stryker Orthopaedics Hip Systems Labeling Update
K233498 · LPH Prosthesis, Hip,... · Orthopedic
Dec 2023 51d
Triathlon? Total Knee System - Triathlon? Pro Posterior Stabilized (PS) Femoral Component
K230952 · JWH Prosthesis, Knee,... · Orthopedic
Jun 2023 59d
Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · KRO Prosthesis, Knee,... · Orthopedic
Apr 2023 203d
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
K222056 · JDI Prosthesis, Hip,... · Orthopedic
Jan 2023 198d
Triathlon? Hinge Knee System
K223528 · KRO Prosthesis, Knee,... · Orthopedic
Jan 2023 58d
UHR Bipolar Implants, Restoration GAP II Implants
K222632 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Oct 2022 51d
Acetabular Dome Hole Plug
K220376 · LPH Prosthesis, Hip,... · Orthopedic
Mar 2022 27d
Restoration? Modular Hip System
K212187 · LPH Prosthesis, Hip,... · Orthopedic
Mar 2022 231d
Exeter? X3? RimFit? Cup
K213701 · JDI Prosthesis, Hip,... · Orthopedic
Feb 2022 69d
Restoration Modular 115mm Conical Distal Stem
K213129 · LZO Prosthesis, Hip,... · Orthopedic
Dec 2021 85d
Avon Patello-femoral Joint Prosthesis
K211303 · KRR Prosthesis, Knee,... · Orthopedic
Jun 2021 36d
Dall-Miles? Cable System
K202016 · JDQ Cerclage, Fixation · Orthopedic
Oct 2020 87d
Triathlon Total KneeSystem
K201343 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2020 51d
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