Cleared Traditional

K070292 - DUROM HIP RESURFACING SYSTEM

K070292 is the FDA 510(k) clearance for DUROM HIP RESURFACING SYSTEM by Zimmer GmbH. It is a Class 2 Orthopedic device (product code KXA) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K070292 · Zimmer GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
85d
Days
Class 2
Risk

K070292 is an FDA 510(k) clearance for the DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on April 26, 2007 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer GmbH devices

Submission Details

510(k) Number K070292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2007
Decision Date April 26, 2007
Days to Decision 85 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KXA Prosthesis, Hip, Femoral, Resurfacing

All 17
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K070292.
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
K092198 · Corin USA · Apr 2010
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673 · Wrightmedicaltechnologyinc · Dec 2008
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053 · Biomet, Inc. · Jun 2007
CONSERVE FEMORAL RESURFACING COMPONENT
K062960 · Wrightmedicaltechnologyinc · Dec 2006
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · Biopro, Inc. · May 2005
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · DePuy Orthopaedics, Inc. · Dec 2003