Cleared Special

K021799 - CEMENTED FEMORAL HEAD RESURFING DEVICE

K021799 is an FDA 510(k) clearance for CEMENTED FEMORAL HEAD RESURFING DEVICE, manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KXA cleared through the Special 510(k) pathway after a 26-day FDA review.

K021799 · Biomet Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
26d
Days
Class 2
Risk

K021799 is an FDA 510(k) clearance for the CEMENTED FEMORAL HEAD RESURFING DEVICE. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 26, 2002 after a review of 26 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 Orthopedics, Inc. devices

FDA 510(k) Submission Details - K021799

510(k) Number K021799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2002
Decision Date June 26, 2002
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

KXA Device Classification - Class 2, Special Controls

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 K021799.
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · Biopro, Inc. · May 2005
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · DePuy Orthopaedics, Inc. · Dec 2003
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · Biomet Orthopedics, Inc. · Dec 2002
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · Corin USA · Feb 2000
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998
MODUILAR UNIPOLAR
K950998 · Intermedics Orthopedics · Apr 1995