Cleared Traditional

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP (K912654) - FDA 510(k) Clearance

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

K912654 · Osteonics Corp. · Orthopedic device
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Aug 1991
Decision
60d
Days
Class 2
Risk

K912654 is an FDA 510(k) clearance for the OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 60 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 K912654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date August 16, 1991
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
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 102
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K912654.
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · Biomet, Inc. · Oct 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · Zimmer, Inc. · Aug 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
K911728 · Osteonics Corp. · Aug 1991
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
K912395 · Howmedica Corp. · Jul 1991
OMNIFIT II EPF HIP STEM SERIES
K911585 · Osteonics Corp. · Jul 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
K910156 · Depuy, Inc. · Jun 1991