Cleared Traditional

GROSS FEMORAL COMPONENT (K001580) - FDA 510(k) Clearance

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

K001580 · Biomet, Inc. · Orthopedic device
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Aug 2000
Decision
87d
Days
Class 2
Risk

K001580 is an FDA 510(k) clearance for the GROSS FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 17, 2000 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Biomet, Inc. devices

Submission Details

510(k) Number K001580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2000
Decision Date August 17, 2000
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 102
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K001580.
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572 · Howmedica Osteonics Corp. · Mar 2002
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676 · Howmedica Osteonics Corp. · Dec 2001
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · Smith & Nephew, Inc. · Dec 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · Howmedica Osteonics Corp. · Aug 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366 · Howmedica Osteonics Corp. · Mar 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
K000242 · Exactech, Inc. · Feb 2000