Cleared Traditional

Triathlon Total Knee System

K173849 · Stryker Orthopaedics · Orthopedic

Feb 2018

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K173849 is an FDA 510(k) clearance for the Triathlon Total Knee System, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on February 2, 2018, 45 days after receiving the submission on December 19, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K173849 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2017
Decision Date	February 02, 2018
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565