510(k) · Cleared

Cleared

Mis Crest Widener

K080458510(k) TraditionalCleared Dec 17, 2008301-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

Mis - Implant Technologies, Ltd. · MQN External Mandibular Fixator And/Or Distractor

Cleared on Dec 17, 2008 as substantially equivalent to K043555 (Synthes (Usa), 2005) and 2 other predicates after a 301-day review. Its family tree reaches back 2 generations to 2000.

Decided: Dec 17, 2008
Review: 301 days
Class: Class II
Product code: MQN
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K002152 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002152 Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus…KLS-Martin L.P. · 2000
1 generation backK042278 Oral Osteodistraction Rod Appliance (Rod 5)Oral Osteodistraction, L.P. · 2005
This deviceK080458 Mis Crest WidenerMis - Implant Technologies, Ltd. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002152	Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction	KLS-Martin L.P.	2000	—
−1	K042278	Oral Osteodistraction Rod Appliance (Rod 5)	Oral Osteodistraction, L.P.	2005	—
0 (this device)	K080458	Mis Crest Widener	Mis - Implant Technologies, Ltd.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K080458, 2000–2008Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K043555	Synthes 9USA) Alveolar Ridge Distractor Summary page 2 …al Devices Panel Predicate Device: 1. Alveolar Ridge Distractor from SYNTHES (USA). P.O.Box 1766, 1690 russell road, paoli, PA 19301 1222 cleared under 510(k) no. K043555. 2. TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY CALLUS DISTRACTION from KLS-Martin, L.P. 3234 ella ln., new port rich…	Synthes (Usa)	2005	—
*	K002152	Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction Summary page 2 …5. 2. TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY CALLUS DISTRACTION from KLS-Martin, L.P. 3234 ella ln., new port richey, FL 34655, cleared under 510(k) no. K002152 3. ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) from ORAL OSTEODISTRACTION L.P., 962 allegro ln. apollo beach, FL 33572, cle…	KLS-Martin L.P.	2000	—
*	K042278	Oral Osteodistraction Rod Appliance (Rod 5) Summary page 2 …510(k) no. K002152 3. ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) from ORAL OSTEODISTRACTION L.P., 962 allegro ln. apollo beach, FL 33572, cleared under 510(k) no. K042278. Description of the device: The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height…	Oral Osteodistraction, L.P.	2005	—

Also cleared against K043555: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K043555.

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. 2008, this device’s year, is highlighted.

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 MIS Crest Widener is intended to:

Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation.

The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080458 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080458: Mis Crest Widener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080458

Report an extraction error

Are you the manufacturer?

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