Cleared Special

VANGUARD PATELLA COMPONENTS

K040770 · Biomet Manufacturing, Inc. · Orthopedic

Apr 2004

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K040770 is an FDA 510(k) clearance for the VANGUARD PATELLA COMPONENTS, 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 April 22, 2004, 28 days after receiving the submission on March 25, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K040770 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2004
Decision Date	April 22, 2004
Days to Decision	28 days
Submission Type	Special
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