Cleared Traditional

Triathlon? Hinge Knee System; Triathlon? Revision Insert X3?

K230416 · Stryker · Orthopedic
May 2023
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K230416 is an FDA 510(k) clearance for the Triathlon? Hinge Knee System; Triathlon? Revision Insert X3?, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Stryker (Malwah, US). The FDA issued a Cleared decision on May 19, 2023, 92 days after receiving the submission on February 16, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K230416 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2023
Decision Date May 19, 2023
Days to Decision 92 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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