Cleared Traditional

K121502 - SYNTHES CURVILINEAR DISTRACTION SYSTEM

K121502 is an FDA 510(k) clearance for SYNTHES CURVILINEAR DISTRACTION SYSTEM, manufactured by Synthes, Inc.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K121502 · Synthes, Inc. · Dental device
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Aug 2012
Decision
94d
Days
Class 2
Risk

K121502 is an FDA 510(k) clearance for the SYNTHES CURVILINEAR DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Synthes, Inc. (West Chester, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 94 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, Inc. devices

FDA 510(k) Submission Details - K121502

510(k) Number K121502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2012
Decision Date August 23, 2012
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
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 47
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K121502.
Internal Distraction - Sterile
K161470 · KLS-Martin L.P. · Dec 2016
Mandible External Fixator - MR Conditional
K143285 · Synthes USA Products, LLC · May 2015
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
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
K063792 · Osteomed LP · Mar 2007