Cleared Traditional

PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS (K073637) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K073637 · Biomet Manufacturing Corp · Orthopedic device
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Mar 2008
Decision
85d
Days
Class 3
Risk

K073637 is an FDA 510(k) clearance for the PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K073637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date March 20, 2008
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 58
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K073637.
PROFEMUR LX 5/8 COATED HIP STEM
K081090 · Wrightmedicaltechnologyinc · May 2008
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
K081007 · Zimmer, Inc. · May 2008
PROFEMUR LX REVISION 5/8 COATED HIP STEM
K080663 · Wrightmedicaltechnologyinc · Apr 2008
DEPUY ASR 300 ACETABULAR CUP SYSTEM
K073413 · DePuy Orthopaedics, Inc. · Jan 2008
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
K071856 · Zimmer, Inc. · Jul 2007
DEPUY ASR TAPER SLEEVE ADAPTER
K070359 · DePuy Orthopaedics, Inc. · Mar 2007