FDA 510(k)

Triathlon® Hinge Knee System

K-Number: K251665 · 2025-07-25

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2025-07-25

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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 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.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

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.