Cleared Special

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ

K051756 · Zimmer Trabecular · Orthopedic

Jul 2005

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K051756 is an FDA 510(k) clearance for the MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on July 27, 2005, 28 days after receiving the submission on June 29, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K051756 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2005
Decision Date	July 27, 2005
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