FDA 510(k) Premarket Notification K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components

Submission Details & Decision

Normalized public record details for 510(k) notification K252044.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K252044

Applicant / Sponsor

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Device Name

Triathlon® Total Knee System - Triathlon® Gold Femoral Components

Product Code

MBH

Decision Date

2025-10-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

2025-06-30

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