510(k) · Cleared
ClearedLorenz Mandibular Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Feb 14, 1996 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 14, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK955640 Lorenz Mandibular DistractorBiomet, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK992873 Lorenz External Mandibular DistractorWalter Lorenz Surgical, Inc. · 1999
- Descendant · 2 generations on · 3 of its ownK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- Descendant · 2 generations on · 2 of its ownK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- Descendant · 3 generations on · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- Descendant · 4 generations on · 0 of its ownK230211 CranioXpandKLS-Martin L.P. · 2023
Most influential descendants
Showing 5 of 5 · See all- K992873Lorenz External Mandibular DistractorWalter Lorenz Surgical, Inc. · 1999 · cites it directly4descendants
- K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004 · 2 generations on3descendants
- K063792Osteomed External Mandibular Distraction SystemOsteomed LP · 2007 · 2 generations on2descendants
- K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013 · 3 generations on1descendant
- K230211CranioXpandKLS-Martin L.P. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955640 | Lorenz Mandibular Distractor | Biomet, Inc. | 1996 | — |
| +1 | K992873 | Lorenz External Mandibular Distractor | Walter Lorenz Surgical, Inc. | 1999 | — |
| +2 | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| +2 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| +3 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| +4 | K230211 | CranioXpand | KLS-Martin L.P. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992873 | Lorenz External Mandibular Distractor | 1999 | 4 |
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?
- Of its descendants, K992873 (Walter Lorenz Surgical, Inc., 1999) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K955640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955640: Lorenz Mandibular Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955640
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026