Cleared Traditional

ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD (K944601) - FDA 510(k) Clearance

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

K944601 · Zimmer, Inc. · Orthopedic device
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Jan 1995
Decision
115d
Days
Class 2
Risk

K944601 is an FDA 510(k) clearance for the ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K944601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date January 12, 1995
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K944601.
APC FEMORAL COMPONENT
K945095 · Howmedica Corp. · Jan 1995
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K945096 · Howmedica Corp. · Jan 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · Howmedica Corp. · Jan 1995
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · Biomet, Inc. · Oct 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942 · Depuy, Inc. · Oct 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847 · Depuy, Inc. · Jul 1994