Cleared Traditional

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

K172326 · Stryker Orthopaedics · Orthopedic

Oct 2017

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K172326 is an FDA 510(k) clearance for the Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on October 30, 2017, 90 days after receiving the submission on August 1, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K172326 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2017
Decision Date	October 30, 2017
Days to Decision	90 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