FDA 510(k)

Triathlon® Total Knee System - Triathlon® Gold Femoral Components

K-Number: K252044 · 2025-10-24

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2025-10-24

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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.

NCT02521103Triathlon Tritanium Cone Augments Outcomes StudyACTIVE_NOT_RECRUITING NCT04358601All-poly Versus Metal-backedACTIVE_NOT_RECRUITING NCT07544264Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial ComponentRECRUITING NCT07207226Arterial Stiffness as a Tool to Investigate Adherence in Resistant HypertensionACTIVE_NOT_RECRUITING

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

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 K251665Triathlon® Hinge Knee System K250989Stryker and Serf hip devices

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Related Devices (Code: MBH)

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.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.