Cleared Traditional

Triathlon PKR System

K203099 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic

Oct 2020

Decision

13d

Days

Class 2

Risk

About This 510(k) Submission

K203099 is an FDA 510(k) clearance for the Triathlon PKR System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on October 27, 2020, 13 days after receiving the submission on October 14, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K203099 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 2020
Decision Date	October 27, 2020
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520