Cleared Traditional

K060138 - SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM

K060138 is an FDA 510(k) clearance for SYNTHES (USA) CRANIOMAXILLOFACIAL DISTR..., 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 134-day FDA review.

K060138 · Synthes (Usa) · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2006
Decision
134d
Days
Class 2
Risk

K060138 is an FDA 510(k) clearance for the SYNTHES (USA) CRANIOMAXILLOFACIAL 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 June 2, 2006 after a review of 134 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 - K060138

510(k) Number K060138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2006
Decision Date June 02, 2006
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
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 52
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K060138.
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
K063792 · Osteomed LP · Mar 2007
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
K062851 · Osteomed LP · Nov 2006
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299 · Synthes (Usa) · Aug 2006
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
K051946 · Medartis, Inc. · Aug 2005
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555 · Synthes (Usa) · Apr 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378 · Synthes (Usa) · Mar 2005