Cleared Traditional

K080153 - SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM

K080153 is an FDA 510(k) clearance for SYNTHES (USA) CURVILINEAR DISTRACTION S..., manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K080153 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
112d
Days
Class 2
Risk

K080153 is an FDA 510(k) clearance for the SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 112 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K080153

510(k) Number K080153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2008
Decision Date May 14, 2008
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQN Device Classification - Class 2, Special Controls

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 51
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K080153.
Mandible External Fixator - MR Conditional
K143285 · Synthes USA Products, LLC · May 2015
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398 · Stryker · Mar 2014
SYNTHES CURVILINEAR DISTRACTION SYSTEM
K121502 · Synthes, Inc. · Aug 2012
KLS MARTIN XTERNAL FIXATOR
K072764 · KLS-Martin L.P. · Dec 2007
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
K063792 · Osteomed LP · Mar 2007
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
K062851 · Osteomed LP · Nov 2006