Cleared Traditional

K143336 - Biomet Microfixation OmniMax MMF System

K143336 is an FDA 510(k) clearance for Biomet Microfixation OmniMax MMF System, manufactured by Biomet Microfixation. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K143336 · Biomet Microfixation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
132d
Days
Class 2
Risk

K143336 is an FDA 510(k) clearance for the Biomet Microfixation OmniMax MMF System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on April 1, 2015 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Microfixation devices

FDA 510(k) Submission Details - K143336

510(k) Number K143336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date April 01, 2015
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K143336.
LeForte System II
K150965 · Jeil Medical Corporation · Sep 2015
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K143730 · Jeil Medical Corporation · Jun 2015
Stryker MEDPOR TITAN 3D Orbital Floor Implant
K142568 · Stryker · May 2015
Argulated Locking Plates
K143338 · Osteomed LP · Apr 2015
MATRIXWAVE MMF SYSTEM
K141165 · Synthes USA Products, LLC · Oct 2014
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
K133461 · Stryker · Aug 2014