510(k) · Cleared

Cleared

Mandibular Bone Distractor II

K960297510(k) TraditionalCleared Aug 6, 1996197-day reviewClass II21 CFR 872.4760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Corp. · MQN External Mandibular Fixator And/Or Distractor

Cleared on Aug 6, 1996 as substantially equivalent to K945674 (Howmedica Corp., 1995) and 3 other predicates after a 197-day review. Its family tree reaches back 1 generation to 1986. 23 later devices descend from it.

Decided: Aug 6, 1996
Review: 197 days
Class: Class II
Product code: MQN
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K864403 (1986). 4 ancestors in all. 23 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK864403 Monticelli Spinelli External Fixation SystemHowmedica Corp. · 1986
This deviceK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
Descendant · cites it directly · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
Descendant · cites it directly · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
Descendant · 2 generations on · 7 of its ownK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
Descendant · 2 generations on · 6 of its ownK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
Descendant · 3 generations on · 5 of its ownK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

1997high 3 (1997) · low 0 (2000)2026

Most influential descendants

Showing 5 of 23 · See all

K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · cites it directly11descendants
K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · cites it directly8descendants
K990944Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999 · 2 generations on7descendants
K013618Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002 · 2 generations on6descendants
K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864403	Monticelli Spinelli External Fixation System	Howmedica Corp.	1986	—
0 (this device)	K960297	Mandibular Bone Distractor II	Howmedica Corp.	1996	—
+1	K972166	Guerrero - Bell Distractor	Howmedica Leibinger, Inc.	1997	—
+1	K972154	Cohen Distractor	Howmedica Leibinger, Inc.	1997	—
+2	K990944	Osteomed Intraoral Distraction System	Osteomed Corp.	1999	—
+2	K013618	Intraoral Mandibular Distraction System	Osteomed Corp.	2002	—
+3	K043434	Osteomed Pediatric Intraoral Mandibular Distraction System	Osteomed LP	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1998	2	0
1999	2	0
2002	2	0
2003	2	0
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2010	1	0
2012	1	0
2013	1	0
2014	2	0
2018	1	0
2019	1	0
2023	1	0

FIG. 1 — Lineage of K960297, 1986–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQN device

#1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall

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What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K945674	Mandibular Bone Distractor Summary page 2 …t to products currently in commercial distribution. A list of these equivalent products may be found below. 1. 2. 3. 4. 5. 6. Mandibular Bone Distractor - Howmedica (K945674) Hoffman Mini Fixator - Howmedica (K792561) Monticelli-Spinelli External Fixator - Howmedica (K864403) Mini Lengthening Apparat…	Howmedica Corp.	1995	—
Kept off the family tree	K792561	FDA’s K792561 is Mini-H-Fixation Our OCR of the scanned summary read K792561, FDA’s number for Mini-H-Fixation (Geny Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hoffman Mini Fixator - Howmedica”. Kept off the family tree. Summary page 2 …bution. A list of these equivalent products may be found below. 1. 2. 3. 4. 5. 6. Mandibular Bone Distractor - Howmedica (K945674) Hoffman Mini Fixator - Howmedica (K792561) Monticelli-Spinelli External Fixator - Howmedica (K864403) Mini Lengthening Apparatus - Synthes (K914558) Normed Device - dist…	Geny Medical, Inc.	1979	—
*	K864403	Monticelli Spinelli External Fixation System Summary page 2 …low. 1. 2. 3. 4. 5. 6. Mandibular Bone Distractor - Howmedica (K945674) Hoffman Mini Fixator - Howmedica (K792561) Monticelli-Spinelli External Fixator - Howmedica (K864403) Mini Lengthening Apparatus - Synthes (K914558) Normed Device - distributed in the United States by Ace Surgical Supply Co. (K#…	Howmedica Corp.	1986	—
*	K914558	Traumafix (TM) External Fixator Summary page 2 …actor - Howmedica (K945674) Hoffman Mini Fixator - Howmedica (K792561) Monticelli-Spinelli External Fixator - Howmedica (K864403) Mini Lengthening Apparatus - Synthes (K914558) Normed Device - distributed in the United States by Ace Surgical Supply Co. (K# unknown) Wells Johnson Fixation System - Wells…	Synthes (Usa)	1992	—
*	K945500	Wells Johnson Fixation System Summary page 2 …paratus - Synthes (K914558) Normed Device - distributed in the United States by Ace Surgical Supply Co. (K# unknown) Wells Johnson Fixation System - Wells Johnson Co. (K945500) The Mandibular Bone Distractor II is similar to the named devices with respect to intended use, material, design, and operation…	Wells Johnson Co.	1995	—
*	—	Normed Device - distributed in the United States by Ace Surgical Supply Co. Named without a submission number			—

Also cleared against K945674: 1 other device →

What descends from it? (23)

See all 23

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K972166	Guerrero - Bell Distractor	Howmedica Leibinger, Inc.	1997	11
K972154	Cohen Distractor	Howmedica Leibinger, Inc.	1997	8
K981362	Synthes (Usa) External Multi Vector Mandible Distractor	Synthes (Usa)	1998	5
K034027	KLS Martin 3DX External Distraction System	KLS-Martin L.P.	2004	3
K984117	Innova Telescopic Distractor	Innova Corp.	1999	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K972166 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K945674.

How does its category compare?

All MQN devices

MQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQN

1in 2022

2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQN

292in 2008

2007high 292 (2008) · low 77 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQN

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQN

34in 2025

2007high 179 (2013) · low 5 (2007)2025

MAUDE reports naming product code MQN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	77	0	5
2008	3	292	0	8
2009	0	—	0	11
2010	0	—	0	20
2011	0	—	0	26
2012	1	—	0	107
2013	0	—	0	179
2014	1	—	1	57
2015	1	—	0	93
2016	1	—	0	87
2017	1	—	0	75
2018	1	—	0	108
2019	1	—	0	122
2020	0	—	0	86
2021	0	—	0	101
2022	1	—	0	61
2023	0	—	0	39
2024	0	—	0	60
2025	0	—	0	34
2026	0	—	0	—

What is it indicated for?

The Mandibular Bone Distractor II is intended to be used in the treatment of conditions such as severe mandibular deficiency, post-surgical mandibular defects, or post-traumatic defects of the mandible. This device is intended to function as a stabilizer and mandibular lengthener. Bone transport procedures may also be performed. This device will allow linear and angular distraction of the mandible. The Mandibular Bone Distractor is intended for use in either adults or children.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960297 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960297: Mandibular Bone Distractor II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960297

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026