Cleared Special

K070359 - DEPUY ASR TAPER SLEEVE ADAPTER

K070359 is an FDA 510(k) clearance for DEPUY ASR TAPER SLEEVE ADAPTER, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Special 510(k) pathway after a 27-day FDA review.

K070359 · DePuy Orthopaedics, Inc. · Orthopedic device
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Mar 2007
Decision
27d
Days
Class 3
Risk

K070359 is an FDA 510(k) clearance for the DEPUY ASR TAPER SLEEVE ADAPTER. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 6, 2007 after a review of 27 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. 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K070359

510(k) Number K070359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2007
Decision Date March 06, 2007
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KWA Device Classification - Class 3, Premarket Approval

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 98
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K070359.
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
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
K062994 · Biomet Manufacturing Corp · 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
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
K062998 · Biomet Manufacturing Corp · Jan 2007