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FDA 510(k)

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

K-Number: K230416 · 2023-05-19

ApplicantStryker
Decision Date2023-05-19
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2023-05-19 under approval 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. It is manufactured by Stryker. The 510(k) number is K230416.

When was Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® approved by the FDA?

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

What company makes Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®?

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is manufactured by Stryker.

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.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING

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Related Devices (Code: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K191779Attune Revision LPS InsertsDepuy(Ireland)

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.

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