Cleared Traditional

K023188 - PRESS-FIT HEAD RESURFACING DEVICE

K023188 is the FDA 510(k) clearance for PRESS-FIT HEAD RESURFACING DEVICE by Biomet Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code KXA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K023188 · Biomet Orthopedics, Inc. · Orthopedic device
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Dec 2002
Decision
78d
Days
Class 2
Risk

K023188 is an FDA 510(k) clearance for the PRESS-FIT HEAD RESURFACING 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 December 11, 2002 after a review of 78 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 Biomet Orthopedics, Inc. devices

Submission Details

510(k) Number K023188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2002
Decision Date December 11, 2002
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 K023188.
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
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · Biomet Orthopedics, Inc. · Jun 2002
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · Corin USA · Feb 2000
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998