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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K253637 ↗

FDA Product Code

MBH

Device Class

Class II

Regulation

21 CFR Part 888.3565

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Triathlon® Knee System

  Class II

  FDA 510(k) K261898 Active Cleared 6 Aug 2026

• Omnifit® 20° Series I Insert Open recall

  Class II

  FDA 510(k) K261624 Active Cleared 10 Jul 2026

• Stryker Orthopaedics Hip Systems Labeling Update

  Class II

  FDA 510(k) K240418 Active Cleared 12 Apr 2024

• UHR Bipolar Implants, Restoration GAP II Implants

  Class II

  FDA 510(k) K222632 Active Cleared 21 Oct 2022

• Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Open recall

  Class II

  FDA 510(k) K172634 Active Cleared 16 Nov 2017

• Restoration Anatomic Shell

  Class II

  FDA 510(k) K210893 Active Cleared 22 Apr 2021

See all devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics →

• What types of knee replacement surgeries is the Triathlon X3 Medial Stabilized Tibial Bearing Insert designed for?

  The Triathlon X3 Medial Stabilized Tibial Bearing Insert is specifically designed for use in both primary and revision total knee arthroplasty procedures. Its asymmetric articulating surface and medial stabilization are engineered to enhance joint stability and alignment, making it suitable for surgeries where improved knee function and sagittal stability are priorities.

• Is this tibial bearing insert compatible with all femoral components, or does it require specific pairing?

  This insert is part of the Triathlon Total Knee System and is intended for use only with compatible femoral components from the same system. The asymmetric design relies on matching geometry to ensure proper articulation and stability, so pairing with non-compatible femoral components could compromise performance.

• How should the Triathlon X3 Medial Stabilized Tibial Bearing Insert be stored and handled before use?

  As a sterile, single-use implant, the insert must be stored and handled according to standard sterile surgical protocols to preserve its integrity. This includes maintaining sealed packaging until immediate preoperative use and adhering to manufacturer guidelines for temperature and humidity control to prevent contamination or degradation.

• What distinguishes the medial stabilization feature of this tibial bearing insert?

  The medial stabilization feature of the Triathlon X3 insert is designed to improve conformity between the tibial plateau and femoral component on the medial side of the knee. This asymmetric articulating surface helps reduce stress concentrations and enhances stability during flexion and extension, particularly for patients requiring precise alignment in total knee replacements.

• Is this device regulated under a specific FDA pathway, and what does that mean for its use?

  The Triathlon X3 Medial Stabilized Tibial Bearing Insert is cleared under the FDA’s 510(k) pathway (K253637) with a determination of *Substantially Equivalent* to a predicate device. This means it has been evaluated by the FDA Orthopedic (OR) Advisory Committee and deemed comparable in safety and effectiveness to an existing orthopedic knee prosthesis, allowing for its use in clinical settings where total knee arthroplasty is performed.