Cleared Traditional

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

K253637 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Feb 2026

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K253637 is an FDA 510(k) clearance for the Triathlon? Total Knee System - Triathlon? X3? Medial Stabilized Tibial Bearing Insert, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on February 18, 2026, 91 days after receiving the submission on November 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K253637 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2025
Decision Date	February 18, 2026
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565