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FDA 510(k)

Triathlon Total Knee System-Additional Components

K-Number: K190402 · 2019-08-22

ApplicantStryker Orthopaedics (Aka Howmedica Osteonics Corp.)
Decision Date2019-08-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon Total Knee System-Additional Components is a medical device manufactured by Stryker Orthopaedics (Aka Howmedica Osteonics Corp.). It received FDA 510(k) clearance on 2019-08-22 under approval number K190402. 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-Additional Components?

Triathlon Total Knee System-Additional Components is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Stryker Orthopaedics (Aka Howmedica Osteonics Corp.). The 510(k) number is K190402.

When was Triathlon Total Knee System-Additional Components approved by the FDA?

Triathlon Total Knee System-Additional Components received FDA 510(k) clearance on 2019-08-22, under approval number K190402.

What company makes Triathlon Total Knee System-Additional Components?

Triathlon Total Knee System-Additional Components is manufactured by Stryker Orthopaedics (Aka Howmedica Osteonics Corp.).

What is the FDA product code for Triathlon Total Knee System-Additional Components?

The FDA product code for Triathlon Total Knee System-Additional Components is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40025985 Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. The bone & joint journal (2025)

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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