Cleared Traditional

K911728 - OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C

K911728 is an FDA 510(k) clearance for OMNIFIT EPF DUAL GEOMTRY/RADIUS/THREAD ..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K911728 · Osteonics Corp. · Orthopedic device
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Aug 1991
Decision
121d
Days
Class 2
Risk

K911728 is an FDA 510(k) clearance for the OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C. 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 121 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K911728

510(k) Number K911728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date August 16, 1991
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K911728.
HA MCCUTCHEN SLT HIP SYSTEM
K912452 · Dow Corning Wright · Oct 1991
DIMENSION-HA HIP PROSTHESIS
K912922 · Kirschner Medical Corp. · Oct 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · Zimmer, Inc. · Aug 1991
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
K912654 · 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