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FDA 510(k)

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

K-Number: K253637 · 2026-02-18

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2026-02-18
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2026-02-18 under approval number K253637. 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® X3® Medial Stabilized Tibial Bearing Insert?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is a medical device that received FDA 510(k) clearance on 2026-02-18. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K253637.

When was Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert approved by the FDA?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert received FDA 510(k) clearance on 2026-02-18, under approval number K253637.

What company makes Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

The FDA product code for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is MBH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K202016Dall-Miles® Cable System K201343Triathlon Total KneeSystem K213129Restoration Modular 115mm Conical Distal Stem K211303Avon Patello-femoral Joint Prosthesis K222632UHR Bipolar Implants, Restoration GAP II Implants K220376Acetabular Dome Hole Plug

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, 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.

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