FDA 510(k)

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®

K-Number: K230416 · 2023-05-19

Decision Date2023-05-19

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230416. 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® Revision Insert X3®?

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Stryker. The 510(k) number is K230416.

When did Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® receive FDA 510(k) clearance?

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230416.

Who is the listed applicant for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®?

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

What is the FDA product code for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®?

The FDA product code for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is KRO.

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Related Devices (Code: 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 K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE™ Revision Hinge KneeDepuy 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.

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.