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FDA 510(k)

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component

K-Number: K230952 · 2023-06-02

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2023-06-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-06-02 under approval number K230952. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component?

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component is a medical device that received FDA 510(k) clearance on 2023-06-02. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K230952.

When was Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component approved by the FDA?

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component received FDA 510(k) clearance on 2023-06-02, under approval number K230952.

What company makes Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component?

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component?

The FDA product code for Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component is JWH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 31564141 The effect of implant modification: the low contact stress experience. The bone & joint journal (2019) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K202016Dall-Miles® Cable System K201343Triathlon Total KneeSystem K213129Restoration Modular 115mm Conical Distal Stem K211303Avon Patello-femoral Joint Prosthesis K222632UHR Bipolar Implants, Restoration GAP II Implants K220376Acetabular Dome Hole Plug

View all 24 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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