FDA 510(k)

Triathlon® Hinge Knee System

N.º K: K251665 · 2025-07-25

SolicitanteHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Fecha de decisión2025-07-25

Código de productoKRO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Triathlon® Hinge 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 2025-07-25 under 510(k) number K251665. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K251665.

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

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

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

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

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Otros registros que enlistan a Howmedica Osteonics Corp., Dba Stryker Orthopaedics como solicitante

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components K250989Stryker and Serf hip devices

Ver todos los 27 dispositivos →

Dispositivos relacionados (Código: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K242871Rodilla de Bisagra Revision ATTUNE™Depuy Ireland UC K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.K233980Sistema de Rodilla Total ATTUNE, Sistema de Rodilla de Cemento Libre ATTUNE, Sistema de Preservación de Miembro LPS, Sistema de Rodilla Parcial de Alto Rendimiento (HP) SIGMADepuy Ireland UC

Fuente oficial

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