Cleared Traditional

K053514 - TRIATHLON TOTAL KNEE SYSTEM
(FDA 510(k) Clearance)

K053514 · Stryker Orthopaedics · Orthopedic

Jan 2006

Decision

41d

Days

Class 2

Risk

K053514 is an FDA 510(k) clearance for the TRIATHLON TOTAL KNEE SYSTEM. This device is classified as 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 January 26, 2006, 41 days after receiving the submission on December 16, 2005.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K053514 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2005
Decision Date	January 26, 2006
Days to Decision	41 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