FDA 510(k)

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

Número K: K261898 · 2026-08-06

RequerenteHowmedica Osteonics Corp. dba Stryker Orthopaedics

Data da decisão2026-08-06

Código do produtoKRO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2026-08-06 under 510(k) number K261898. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System?

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Howmedica Osteonics Corp. dba Stryker Orthopaedics. The 510(k) number is K261898.

When did Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System receive FDA 510(k) clearance?

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System received FDA 510(k) clearance on 2026-08-06, under 510(k) number K261898.

Who is the listed applicant for Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System?

The FDA 510(k) record lists Howmedica Osteonics Corp. dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

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

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

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Outros registros que listam Howmedica Osteonics Corp. dba Stryker Orthopaedics como candidato(a)

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Dispositivos Relacionados (Código: KRO)

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