Cleared Traditional

OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD (K925695) - FDA 510(k) Clearance

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

K925695 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1993
Decision
159d
Days
Class 2
Risk

K925695 is an FDA 510(k) clearance for the OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 159 days - an extended review 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: 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 Osteonics Corp. devices

Submission Details

510(k) Number K925695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date April 20, 1993
Days to Decision 159 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
37d slower than avg
Panel avg: 122d · This submission: 159d
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 K925695.
BIMETRIC TOTAL HIP SYSTEM
K921224 · Biomet, Inc. · Feb 1994
INTEGRAL TOTAL HIP SYSTEM
K921225 · Biomet, Inc. · Feb 1994
WALKER HIP PROSTHESIS
K915222 · Zimmer, Inc. · Jun 1993
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · Biomet, Inc. · Nov 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K915396 · Osteonics Corp. · Oct 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
K920577 · Howmedica Corp. · May 1992