Cleared Special

FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) (K081067) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081067 · Biomet Microfixation, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
24d
Days
Class 2
Risk

K081067 is an FDA 510(k) clearance for the FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomet Microfixation, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 9, 2008 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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, Inc. devices

Submission Details

510(k) Number K081067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2008
Decision Date May 09, 2008
Days to Decision 24 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 93
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K081067.
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
K091144 · Synthes (Usa) · Aug 2009
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
K083388 · Synthes (Usa) · Mar 2009
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K082335 · Synthes (Usa) · Nov 2008
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
K080331 · Synthes (Usa) · Apr 2008
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · Synthes (Usa) · Apr 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007