Cleared Traditional

Triathlon? Total Knee System - Triathlon? Gold Femoral Components

K252044 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic
Oct 2025
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K252044 is an FDA 510(k) clearance for the Triathlon? Total Knee System - Triathlon? Gold Femoral Components, 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 October 24, 2025, 116 days after receiving the submission on June 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number K252044 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2025
Decision Date October 24, 2025
Days to Decision 116 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

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