Cleared Traditional

Triathlon? Hinge Knee System

K251665 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic
Jul 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K251665 is an FDA 510(k) clearance for the Triathlon? Hinge Knee System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on July 25, 2025, 56 days after receiving the submission on May 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K251665 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date July 25, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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