Cleared Traditional

ZIRCONIUM ALLOY UNI-POLAR HEAD (K934353) - FDA 510(k) Clearance

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

K934353 · Smith & Nephew Richards, Inc. · Orthopedic device
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Apr 1994
Decision
229d
Days
Class 2
Risk

K934353 is an FDA 510(k) clearance for the ZIRCONIUM ALLOY UNI-POLAR HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 229 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K934353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1993
Decision Date April 25, 1994
Days to Decision 229 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 122d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 50
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K934353.
UNITRAX V40 MODULAR ADAPTOR
K954077 · Howmedica Corp. · Nov 1995
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K943778 · Osteonics Corp. · Aug 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563 · Johnson & Johnson Professionals, Inc. · Jun 1995
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120 · Depuy, Inc. · Mar 1993
OSTRONCS HEMI-HIP STEM SERIES
K922146 · Osteonics Corp. · Aug 1992
MTS FEMORAL HIP SYSTEM
K903877 · 3M Company · Jan 1991