Cleared Traditional

23 MM SINGLE-PEG PATELLA COMPONENT

K061340 · Biomet Manufacturing, Inc. · Orthopedic

Sep 2006

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K061340 is an FDA 510(k) clearance for the 23 MM SINGLE-PEG PATELLA COMPONENT, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 25, 2006, 133 days after receiving the submission on May 15, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K061340 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2006
Decision Date	September 25, 2006
Days to Decision	133 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