Cleared Traditional

K894694 - OMNIFIT CERAMIC MORSE TAPER HEAD

K894694 is the FDA 510(k) clearance for OMNIFIT CERAMIC MORSE TAPER HEAD by Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K894694 · Osteonics Corp. · Orthopedic device
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Oct 1989
Decision
80d
Days
Class 2
Risk

K894694 is an FDA 510(k) clearance for the OMNIFIT CERAMIC MORSE TAPER 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 October 12, 1989 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 Osteonics Corp. devices

Submission Details

510(k) Number K894694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 12, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
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 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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K894694.
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
K894904 · Kinamed, Inc. · Mar 1990
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399 · Dow Corning Wright · Dec 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204 · Richards Medical Co., Inc. · Nov 1989
CERAMIC FEMORAL HEAD
K893685 · Dow Corning Wright · Sep 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · Richards Medical Co., Inc. · Sep 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472 · Kinamed, Inc. · Sep 1989