Cleared Traditional

K133398 - STRYKER PEDIATRIC MANDIBLE DISTRACTOR

K133398 is the FDA 510(k) clearance for STRYKER PEDIATRIC MANDIBLE DISTRACTOR by Stryker. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K133398 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
134d
Days
Class 2
Risk

K133398 is an FDA 510(k) clearance for the STRYKER PEDIATRIC MANDIBLE DISTRACTOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on March 20, 2014 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 Stryker devices

Submission Details

510(k) Number K133398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date March 20, 2014
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.

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 30
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K133398.
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
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
K080153 · Synthes (Usa) · May 2008
KLS MARTIN XTERNAL FIXATOR
K072764 · KLS-Martin L.P. · Dec 2007
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299 · Synthes (Usa) · Aug 2006