Cleared Special

PROFEMUR RENAISSANCE HIP STEM

K051995 · Wrightmedicaltechnologyinc · Orthopedic

Aug 2005

Decision

28d

Days

Class 3

Risk

About This 510(k) Submission

K051995 is an FDA 510(k) clearance for the PROFEMUR RENAISSANCE HIP STEM, a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III — Premarket Approval, product code JDL), submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 22, 2005, 28 days after receiving the submission on July 25, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K051995 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2005
Decision Date	August 22, 2005
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 888.3320