Cleared Traditional

K960297 - MANDIBULAR BONE DISTRACTOR II

K960297 is an FDA 510(k) clearance for MANDIBULAR BONE DISTRACTOR II, manufactured by Howmedica Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K960297

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.

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 52
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
NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
K952847 · Ace Surgical Supply Co., Inc. · Feb 1996
MANDIBULAR BONE DISTRACTOR
K945674 · Howmedica Corp. · Jun 1995