510(k) · Cleared
ClearedOsteomed Maxillary/Lefort Iii Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · MQN External Mandibular Fixator And/Or Distractor
Cleared on Nov 3, 2003 as substantially equivalent to K972154 (Howmedica Leibinger, Inc., 1997) and 1 other predicate after a 154-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Nov 3, 2003
- Review
- 154 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K792561 (1979). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 4 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 3 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 2 generations backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- 1 generation backK982604 Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc. · 1998
- This deviceK031708 Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −4 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −3 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K982604 | Lorenz Maxilla (LE Fort) Distraction System | Walter Lorenz Surgical, Inc. | 1998 | — |
| 0 (this device) | K031708 | Osteomed Maxillary/Lefort Iii Distraction System | Osteomed LP | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K972154 | Cohen DistractorSummary page 1…evice is based on similarities in intended use, material, design and operational principle to the Howmedica Leibinger Cohen Distractor (K972154)and the Lorenz Maxilla Distraction System (K982604). Due to the similarity of materials and design to predicate… | 1997 |
| * | K982604 | Lorenz Maxilla (LE Fort) Distraction SystemSummary page 1…erial, design and operational principle to the Howmedica Leibinger Cohen Distractor (K972154)and the Lorenz Maxilla Distraction System (K982604). Due to the similarity of materials and design to predicate devices, OsteoMed believes that th… | 1998 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 14 ancestors has a recall.
- 4 other devices also cite its predicate K972154.
How does its category compare?
All MQN devicesMQN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 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?
Intended for use in the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / LeFort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.
The OsteoMed Maxillary / LeFort III Distraction System is intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031708 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031708: Osteomed Maxillary/Lefort Iii Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031708
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