Cleared Special

K121589 - BIOMET MICROFIXATION FACIAL PLATING SYSTEM

K121589 is an FDA 510(k) clearance for BIOMET MICROFIXATION FACIAL PLATING SYSTEM, manufactured by Biomet Microfixation. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 113-day FDA review.

K121589 · Biomet Microfixation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
113d
Days
Class 2
Risk

K121589 is an FDA 510(k) clearance for the BIOMET MICROFIXATION FACIAL PLATING 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 September 21, 2012 after a review of 113 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet Microfixation devices

FDA 510(k) Submission Details - K121589

510(k) Number K121589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date September 21, 2012
Days to Decision 113 days
Submission Type Special
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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

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 K121589.
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