Cleared Traditional

K994153 - CORMET 2000 HEMI HIP METALLIC RESURFACI...

K994153 is an FDA 510(k) clearance for CORMET 2000 HEMI HIP METALLIC RESURFACI..., 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 79-day FDA review.

K994153 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
79d
Days
Class 2
Risk

K994153 is an FDA 510(k) clearance for the CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS. 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 February 25, 2000 after a review of 79 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 Corin USA devices

FDA 510(k) Submission Details - K994153

510(k) Number K994153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date February 25, 2000
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 K994153.
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · DePuy Orthopaedics, Inc. · Dec 2003
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · Biomet Orthopedics, Inc. · Dec 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · Biomet Orthopedics, Inc. · Jun 2002
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998
MODUILAR UNIPOLAR
K950998 · Intermedics Orthopedics · Apr 1995
ORTHOMET RESURFACING FEMORAL COMPONENT
K944752 · Orthomet, Inc. · Dec 1994