Cleared Traditional

GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER

K052639 · Biomet Manufacturing, Inc. · Orthopedic
May 2006
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K052639 is an FDA 510(k) clearance for the GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 3, 2006, 219 days after receiving the submission on September 26, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K052639 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2005
Decision Date May 03, 2006
Days to Decision 219 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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