Cleared Traditional

K071628 - STRYKER EXTERNAL FIXATION SYSTEM

K071628 is the FDA 510(k) clearance for STRYKER EXTERNAL FIXATION SYSTEM by Stryker Cmf. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K071628 · Stryker Cmf · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
57d
Days
Class 2
Risk

K071628 is an FDA 510(k) clearance for the STRYKER EXTERNAL FIXATION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Stryker Cmf (Kalamazoo, US). The FDA issued a Cleared decision on August 10, 2007 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Cmf devices

Submission Details

510(k) Number K071628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2007
Decision Date August 10, 2007
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 127d · This submission: 57d
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 39
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K071628.
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398 · Stryker · Mar 2014
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
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
K060138 · Synthes (Usa) · Jun 2006
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555 · Synthes (Usa) · Apr 2005