Cleared Traditional

K143285 - Mandible External Fixator - MR Conditional

K143285 is the FDA 510(k) clearance for Mandible External Fixator - MR Conditional by Synthes USA Products, LLC. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K143285 · Synthes USA Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
192d
Days
Class 2
Risk

K143285 is an FDA 510(k) clearance for the Mandible External Fixator - MR Conditional. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on May 28, 2015 after a review of 192 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. 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K143285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2014
Decision Date May 28, 2015
Days to Decision 192 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
65d slower than avg
Panel avg: 127d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQN External Mandibular Fixator And/or Distractor
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 - MQN External Mandibular Fixator And/or Distractor

All 38
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K143285.
Stryker Pediatric Mandibular Distractor 2
K181504 · Stryker · Sep 2018
Craniomaxillofacial Distraction System (CMFD)
K162594 · Synthes USA Products, LLC · May 2017
Internal Distraction - Sterile
K161470 · KLS-Martin L.P. · Dec 2016
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398 · Stryker · Mar 2014
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
K080153 · Synthes (Usa) · May 2008
KLS MARTIN XTERNAL FIXATOR
K072764 · KLS-Martin L.P. · Dec 2007