Cleared Traditional

CONSENSUS ACETABLAR SHELL, TI COATED (K020153) - FDA 510(k) Clearance

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

K020153 · Hayes Medical, Inc. · Orthopedic device
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Apr 2002
Decision
89d
Days
Class 2
Risk

K020153 is an FDA 510(k) clearance for the CONSENSUS ACETABLAR SHELL, TI COATED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on April 15, 2002 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K020153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date April 15, 2002
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K020153.
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070 · Zimmer, Inc. · Jul 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346 · Wrightmedicaltechnologyinc · Jul 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · Howmedica Osteonics Corp. · Jul 2002
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K020580 · Biomet, Inc. · Mar 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE
K012787 · Smith & Nephew, Inc. · Mar 2002
TRIDENT ELEVATED RIM LINER
K020497 · Howmedica Osteonics Corp. · Mar 2002