Cleared Traditional

K031708 - OSTEOMED MAXILLARY/LEFORT III DISTRACTI...

K031708 is the FDA 510(k) clearance for OSTEOMED MAXILLARY/LEFORT III DISTRACTI... by Osteomed LP. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K031708 · Osteomed LP · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2003
Decision
154d
Days
Class 2
Risk

K031708 is an FDA 510(k) clearance for the OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on November 3, 2003 after a review of 154 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 LP devices

Submission Details

510(k) Number K031708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date November 03, 2003
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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 K031708.
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169 · Synthes (Usa) · Apr 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · Synthes (Usa) · Mar 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027 · KLS-Martin L.P. · Feb 2004
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · KLS-Martin L.P. · Oct 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · Synthes (Usa) · Oct 2003
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696 · Walter Lorenz Surgical, Inc. · Jun 2003