Cleared Traditional

K133398 - STRYKER PEDIATRIC MANDIBLE DISTRACTOR

K133398 is an FDA 510(k) clearance for STRYKER PEDIATRIC MANDIBLE DISTRACTOR, manufactured by Stryker. 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.

K133398 · Stryker · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K133398

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
6d slower than avg
Panel avg: 128d · 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 59
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K133398.
Craniomaxillofacial Distraction System (CMFD)
K162594 · Synthes USA Products, LLC · May 2017
Internal Distraction - Sterile
K161470 · KLS-Martin L.P. · Dec 2016
Mandible External Fixator - MR Conditional
K143285 · Synthes USA Products, LLC · May 2015
SYNTHES CURVILINEAR DISTRACTION SYSTEM
K121502 · Synthes, Inc. · Aug 2012
MIS CREST WIDENER
K080458 · Mis - Implant Technologies , Ltd. · Dec 2008
DISTRAX
K080542 · John W. King · Dec 2008
K133398 · STRYKER PEDIATRIC MANDIBLE DISTRACTOR
Download PDF FDA Summary Stryker