FDA 510(k)

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

Numéro K : K261898 · 2026-08-06

DemandeurHowmedica Osteonics Corp. dba Stryker Orthopaedics

Date de décision2026-08-06

Code produitKRO

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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

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Dispositifs connexes (Code : KRO)

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 K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871Genou à charnière ATTUNE® RévisionDepuy 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.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

Source officielle

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