Cleared Special

K112457 - LEFORTE SYSTEM BONE PLATE & SCREW

K112457 is an FDA 510(k) clearance for LEFORTE SYSTEM BONE PLATE & SCREW, manufactured by Arkin Consulting Group. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 266-day FDA review.

K112457 · Arkin Consulting Group · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
266d
Days
Class 2
Risk

K112457 is an FDA 510(k) clearance for the LEFORTE SYSTEM BONE PLATE & SCREW. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Arkin Consulting Group (Marietta, US). The FDA issued a Cleared decision on May 18, 2012 after a review of 266 days - an extended review 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. 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.

FDA 510(k) Submission Details - K112457

510(k) Number K112457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2011
Decision Date May 18, 2012
Days to Decision 266 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
138d slower than avg
Panel avg: 128d · This submission: 266d
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 290
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K112457.
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
K113512 · Biomet Microfixation · Jun 2012
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K121574 · Synthes, Inc. · Jun 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
RESORB X-G
K112064 · KLS-Martin L.P. · Mar 2012
NEO TITANIUM MESH, CTI-MEM
K111761 · Neobiotech Co., Ltd. · Jan 2012
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
K113251 · Synthes, Inc. · Dec 2011
K112457 · LEFORTE SYSTEM BONE PLATE & SCREW
Download PDF FDA Summary Arkin Consulting Group