Cleared Traditional

K000992 - MACROPOREDX DISTRACTOR SYSTEM

K000992 is an FDA 510(k) clearance for MACROPOREDX DISTRACTOR SYSTEM, manufactured by Macropore Biosurgery, Inc.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000992 · Macropore Biosurgery, Inc. · Dental device
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Jun 2000
Decision
90d
Days
Class 2
Risk

K000992 is an FDA 510(k) clearance for the MACROPOREDX DISTRACTOR SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on June 26, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Macropore Biosurgery, Inc. devices

FDA 510(k) Submission Details - K000992

510(k) Number K000992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2000
Decision Date June 26, 2000
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 46
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K000992.
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
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
K000580 · KLS-Martin L.P. · Jul 2000
LORENZ DISTRACTION SYSTEM
K992952 · Walter Lorenz Surgical, Inc. · Nov 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · Walter Lorenz Surgical, Inc. · Sep 1999
K-L-W INTRAORAL DISTRACTOR
K991875 · KLS-Martin L.P. · Aug 1999