Cleared Traditional

K201343 - Triathlon Total KneeSystem
(FDA 510(k) Clearance)

K201343 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Jul 2020

Decision

51d

Days

Class 2

Risk

K201343 is an FDA 510(k) clearance for the Triathlon Total KneeSystem, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on July 10, 2020, 51 days after receiving the submission on May 20, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K201343 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2020
Decision Date	July 10, 2020
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560