Cleared Special

ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM (K081007) - FDA 510(k) Clearance

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

K081007 · Zimmer, Inc. · Orthopedic device
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May 2008
Decision
28d
Days
Class 3
Risk

K081007 is an FDA 510(k) clearance for the ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM. 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 May 6, 2008 after a review of 28 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 K081007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2008
Decision Date May 06, 2008
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 57
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K081007.
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
K082446 · Biomet, Inc. · Oct 2008
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
K080991 · DePuy Orthopaedics, Inc. · Jul 2008
PROFEMUR LX 5/8 COATED HIP STEM
K081090 · Wrightmedicaltechnologyinc · 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