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FDA 510(k)

Triathlon® Hinge Knee System

K-Number: K251665 · 2025-07-25

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2025-07-25
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon® Hinge Knee System is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2025-07-25 under approval number K251665. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon® Hinge Knee System?

Triathlon® Hinge Knee System is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K251665.

When was Triathlon® Hinge Knee System approved by the FDA?

Triathlon® Hinge Knee System received FDA 510(k) clearance on 2025-07-25, under approval number K251665.

What company makes Triathlon® Hinge Knee System?

Triathlon® Hinge Knee System is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Triathlon® Hinge Knee System?

The FDA product code for Triathlon® Hinge Knee System is KRO.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING

Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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Related Devices (Code: KRO)

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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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