Cleared Traditional

REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS

K053505 · Biomet Manufacturing, Inc. · Orthopedic

Aug 2006

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K053505 is an FDA 510(k) clearance for the REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 14, 2006, 241 days after receiving the submission on December 16, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K053505 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2005
Decision Date	August 14, 2006
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565