Cleared Special

K062994 - LATERALIZED TAPERLOC MICROPLASTY FEMORA...

K062994 is the FDA 510(k) clearance for LATERALIZED TAPERLOC MICROPLASTY FEMORA... by Biomet Manufacturing Corp. It is a Class 3 Orthopedic device (product code KWA) cleared through the Special 510(k) pathway after a 158-day FDA review.

K062994 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
158d
Days
Class 3
Risk

K062994 is an FDA 510(k) clearance for the LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS. 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 9, 2007 after a review of 158 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 K062994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date March 09, 2007
Days to Decision 158 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

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 92
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K062994.
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
K071856 · Zimmer, Inc. · Jul 2007
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
K070221 · Encore Medical, L.P. · Apr 2007
ECHO BI-METRIC PRESS-FIT STEMS
K070274 · Biomet Manufacturing Corp · Apr 2007
DEPUY ASR TAPER SLEEVE ADAPTER
K070359 · DePuy Orthopaedics, Inc. · Mar 2007
ALTRA FX HIP SYSTEM
K063614 · Biomet Manufacturing Corp · Feb 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
K063251 · Zimmer, Inc. · Jan 2007