Cleared Traditional

K021549 - CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM

K021549 is an FDA 510(k) clearance for CONTOURED ARTICULAR PROSTHESIS (CAP) FE..., manufactured by Std Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K021549 · Std Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
80d
Days
Class 2
Risk

K021549 is an FDA 510(k) clearance for the CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Std Mfg., Inc. (Stoughton, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 80 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 Std Mfg., Inc. devices

FDA 510(k) Submission Details - K021549

510(k) Number K021549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2002
Decision Date August 01, 2002
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
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 18
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K021549.
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
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