Cleared Traditional

TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P

K123166 · Howmedica Osteonics Corp. · Orthopedic

Feb 2013

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K123166 is an FDA 510(k) clearance for the TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on February 14, 2013, 128 days after receiving the submission on October 9, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K123166 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2012
Decision Date	February 14, 2013
Days to Decision	128 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