Cleared Traditional

CONSENSUS UNIPOLAR HEAD, COCR (K030205) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030205 · Hayes Medical, Inc. · Orthopedic device
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Apr 2003
Decision
70d
Days
Class 2
Risk

K030205 is an FDA 510(k) clearance for the CONSENSUS UNIPOLAR HEAD, COCR. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on April 1, 2003 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Hayes Medical, Inc. devices

Submission Details

510(k) Number K030205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date April 01, 2003
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 50
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K030205.
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · Smith & Nephew, Inc. · Sep 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · Exactech, Inc. · Jan 2004
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · Howmedica Osteonics Corp. · Jan 2002
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · Howmedica Osteonics Corp. · Sep 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · Osteonics Corp. · Feb 1999