Cleared Special

K071856 - ZIMMER M/L TAPER HIP PROSTHESIS WITH KI...

K071856 is the FDA 510(k) clearance for ZIMMER M/L TAPER HIP PROSTHESIS WITH KI... by Zimmer, Inc.. It is a Class 3 Orthopedic device (product code KWA) cleared through the Special 510(k) pathway after a 25-day FDA review.

K071856 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
25d
Days
Class 3
Risk

K071856 is an FDA 510(k) clearance for the ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 784.... Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 25 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 Zimmer, Inc. devices

Submission Details

510(k) Number K071856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date July 30, 2007
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 K071856.
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
K073637 · Biomet Manufacturing Corp · Mar 2008
ZIMMER POROLOCK MIS STEM
K071723 · Zimmer GmbH · Mar 2008
DEPUY ASR 300 ACETABULAR CUP SYSTEM
K073413 · DePuy Orthopaedics, Inc. · Jan 2008
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