Cleared Traditional

K162594 - Craniomaxillofacial Distraction System (CMFD)

K162594 is an FDA 510(k) clearance for Craniomaxillofacial Distraction System ..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K162594

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.

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 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