Cleared Traditional

K960297 - MANDIBULAR BONE DISTRACTOR II

K960297 is the FDA 510(k) clearance for MANDIBULAR BONE DISTRACTOR II by Howmedica Corp.. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K960297 · Howmedica Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
197d
Days
Class 2
Risk

K960297 is an FDA 510(k) clearance for the MANDIBULAR BONE DISTRACTOR II. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 6, 1996 after a review of 197 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 Howmedica Corp. devices

Submission Details

510(k) Number K960297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date August 06, 1996
Days to Decision 197 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
70d slower than avg
Panel avg: 127d · This submission: 197d
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 38
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K960297.
SYNTHES MINI LENGTHENING APPARATUS
K973018 · Synthes (Usa) · Nov 1997
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
K972047 · KLS-Martin L.P. · Jun 1997
SYNTHES MANDIBLE DISTRACTOR
K962272 · Synthes (Usa) · Aug 1996
LORENZ MANDIBULAR DISTRACTOR
K955640 · Biomet, Inc. · Feb 1996
MANDIBULAR BONE DISTRACTOR
K945674 · Howmedica Corp. · Jun 1995