Cleared Traditional

OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM (K043434) - FDA 510(k) Clearance

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

K043434 · Osteomed LP · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
59d
Days
Class 2
Risk

K043434 is an FDA 510(k) clearance for the OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR 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 February 10, 2005 after a review of 59 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 Osteomed LP devices

Submission Details

510(k) Number K043434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date February 10, 2005
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
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 K043434.
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
K060138 · Synthes (Usa) · Jun 2006
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555 · Synthes (Usa) · Apr 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378 · Synthes (Usa) · Mar 2005
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