Cleared Traditional

K092198 - CORMET CEMENTLESS RESURFACING FEMORAL HEAD

K092198 is an FDA 510(k) clearance for CORMET CEMENTLESS RESURFACING FEMORAL HEAD, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K092198 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
268d
Days
Class 2
Risk

K092198 is an FDA 510(k) clearance for the CORMET CEMENTLESS RESURFACING FEMORAL HEAD. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on April 15, 2010 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Corin USA devices

FDA 510(k) Submission Details - K092198

510(k) Number K092198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date April 15, 2010
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K092198.
Biocore9 Femoral Head Resurfacing Component
K201219 · Biocore9, LLC · Jan 2021
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673 · Wrightmedicaltechnologyinc · Dec 2008
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053 · Biomet, Inc. · Jun 2007
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