Cleared Special

K071053 - RECAP HA PRESS-FIT FEMORAL RESURFACING ...

K071053 is the FDA 510(k) clearance for RECAP HA PRESS-FIT FEMORAL RESURFACING ... by Biomet, Inc.. It is a Class 2 Orthopedic device (product code KXA) cleared through the Special 510(k) pathway after a 77-day FDA review.

K071053 · Biomet, Inc. · Orthopedic device
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Jun 2007
Decision
77d
Days
Class 2
Risk

K071053 is an FDA 510(k) clearance for the RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 77 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K071053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2007
Decision Date June 29, 2007
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 K071053.
Biocore9 Femoral Head Resurfacing Component
K201219 · Biocore9, LLC · Jan 2021
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
K092198 · Corin USA · Apr 2010
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673 · Wrightmedicaltechnologyinc · Dec 2008
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
K070292 · Zimmer GmbH · Apr 2007
CONSERVE FEMORAL RESURFACING COMPONENT
K062960 · Wrightmedicaltechnologyinc · Dec 2006
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · Biopro, Inc. · May 2005