Cleared Traditional

K013618 - INTRAORAL MANDIBULAR DISTRACTION SYSTEM

K013618 is an FDA 510(k) clearance for INTRAORAL MANDIBULAR DISTRACTION SYSTEM, manufactured by Osteomed Corp.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K013618 · Osteomed Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
282d
Days
Class 2
Risk

K013618 is an FDA 510(k) clearance for the INTRAORAL MANDIBULAR DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 282 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 Osteomed Corp. devices

FDA 510(k) Submission Details - K013618

510(k) Number K013618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date August 14, 2002
Days to Decision 282 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
155d slower than avg
Panel avg: 127d · This submission: 282d
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 45
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K013618.
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · Synthes (Usa) · Oct 2003
OSTEOMED ALVEOLAR DISTRACTION SYSTEM
K030790 · Osteomed LP · Sep 2003
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696 · Walter Lorenz Surgical, Inc. · Jun 2003
LORENZ BLUE DEVICE
K020407 · Walter Lorenz Surgical, Inc. · Feb 2002
ZURICH DISTRACTION SYSTEM
K010139 · KLS-Martin L.P. · Jun 2001
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
K002152 · KLS-Martin L.P. · Oct 2000