FDA 510(k)

Triathlon® Total Knee System - Triathlon® Gold Femoral Components

Numéro K : K252044 · 2025-10-24

DemandeurHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Date de décision2025-10-24

Code produitMBH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Triathlon® Total Knee System - Triathlon® Gold Femoral Components 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 2025-10-24 under 510(k) number K252044. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K252044.

When did Triathlon® Total Knee System - Triathlon® Gold Femoral Components receive FDA 510(k) clearance?

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

Who is the listed applicant for Triathlon® Total Knee System - Triathlon® Gold Femoral Components?

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® Total Knee System - Triathlon® Gold Femoral Components?

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

Essais cliniques associés

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Autres dossiers indiquant Howmedica Osteonics Corp., Dba Stryker Orthopaedics en tant que demandeur

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 K250989Stryker and Serf hip devices K251665Triathlon® Hinge Knee System

Voir tous les 27 dispositifs →

Dispositifs connexes (Code : MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

Source officielle

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