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FDA 510(k)

Triathlon® Total Knee System - Triathlon® Gold Femoral Components

K-Number: K252044 · 2025-10-24

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2025-10-24
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon® Total Knee System - Triathlon® Gold Femoral Components is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2025-10-24 under approval number K252044. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon® Total Knee System - Triathlon® Gold Femoral Components?

Triathlon® Total Knee System - Triathlon® Gold Femoral Components is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K252044.

When was Triathlon® Total Knee System - Triathlon® Gold Femoral Components approved by the FDA?

Triathlon® Total Knee System - Triathlon® Gold Femoral Components received FDA 510(k) clearance on 2025-10-24, under approval number K252044.

What company makes Triathlon® Total Knee System - Triathlon® Gold Femoral Components?

Triathlon® Total Knee System - Triathlon® Gold Femoral Components is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Triathlon® Total Knee System - Triathlon® Gold Femoral Components?

The FDA product code for Triathlon® Total Knee System - Triathlon® Gold Femoral Components is MBH.

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)

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

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

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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