Cleared Traditional

DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 (K014001) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014001 · Oral Osteodistraction, L.P. · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
427d
Days
Class 2
Risk

K014001 is an FDA 510(k) clearance for the DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Oral Osteodistraction, L.P. (Appollo Beach, US). The FDA issued a Cleared decision on February 4, 2003 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Oral Osteodistraction, L.P. devices

Submission Details

510(k) Number K014001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date February 04, 2003
Days to Decision 427 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
300d slower than avg
Panel avg: 127d · This submission: 427d
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 18
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K014001.
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169 · Synthes (Usa) · Apr 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · Synthes (Usa) · Mar 2004
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · Synthes (Usa) · Oct 2003
SYNTHES (USA) RATCHETING DISTRACTOR
K981275 · Synthes (Usa) · Jun 1998
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
K981075 · Synthes (Usa) · Jun 1998
SYNTHES MINI LENGTHENING APPARATUS
K973018 · Synthes (Usa) · Nov 1997