Cleared Traditional

K162594 - Craniomaxillofacial Distraction System ...

K162594 is the FDA 510(k) clearance for Craniomaxillofacial Distraction System ... by Synthes USA Products, LLC. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K162594 · Synthes USA Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
234d
Days
Class 2
Risk

K162594 is an FDA 510(k) clearance for the Craniomaxillofacial Distraction System (CMFD). 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 8, 2017 after a review of 234 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 K162594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2016
Decision Date May 08, 2017
Days to Decision 234 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
107d slower than avg
Panel avg: 127d · This submission: 234d
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 K162594.
KLS Martin IPS Distraction
K220050 · KLS-Martin L.P. · Aug 2022
DePuy Synthes Maxillofacial Portfolio - MR Conditional
K183113 · Synthes USA Products, LLC · Mar 2019
Stryker Pediatric Mandibular Distractor 2
K181504 · Stryker · Sep 2018
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