Cleared Traditional

K994366 - TMZF PRESS FIT HA STEM AND TMZF PRESS F...

K994366 is the FDA 510(k) clearance for TMZF PRESS FIT HA STEM AND TMZF PRESS F... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K994366 · Howmedica Osteonics Corp. · Orthopedic device
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Mar 2000
Decision
80d
Days
Class 2
Risk

K994366 is an FDA 510(k) clearance for the TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on March 16, 2000 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K994366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date March 16, 2000
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 130
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K994366.
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · Smith & Nephew, Inc. · Dec 2000
GROSS FEMORAL COMPONENT
K001580 · Biomet, Inc. · Aug 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · Howmedica Osteonics Corp. · Aug 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
K000242 · Exactech, Inc. · Feb 2000
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
K993943 · Encore Orthopedics, Inc. · Feb 2000
CITATION TMZF HA STEM
K993768 · Howmedica Osteonics Corp. · Jan 2000