Cleared Traditional

K993768 - CITATION TMZF HA STEM

K993768 is the FDA 510(k) clearance for CITATION TMZF HA STEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K993768 · Howmedica Osteonics Corp. · Orthopedic device
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Jan 2000
Decision
74d
Days
Class 2
Risk

K993768 is an FDA 510(k) clearance for the CITATION TMZF 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 January 21, 2000 after a review of 74 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 K993768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date January 21, 2000
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 K993768.
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
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
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
K993077 · Howmedica Osteonics Corp. · Oct 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025 · Howmedica Osteonics Corp. · Aug 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
K990666 · Smith & Nephew, Inc. · Aug 1999