510(k) · Cleared
ClearedLorenz External Mandibular Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Sep 17, 1999 as substantially equivalent to K955640 (Biomet, Inc., 1996) after a 22-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Sep 17, 1999
- Review
- 22 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955640 (1996). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955640 Lorenz Mandibular DistractorBiomet, Inc. · 1996
- This deviceK992873 Lorenz External Mandibular DistractorWalter Lorenz Surgical, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- Descendant · cites it directly · 2 of its ownK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- Descendant · 2 generations on · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- Descendant · 3 generations on · 0 of its ownK230211 CranioXpandKLS-Martin L.P. · 2023
Most influential descendants
Showing 4 of 4 · See all- K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004 · cites it directly3descendants
- K063792Osteomed External Mandibular Distraction SystemOsteomed LP · 2007 · cites it directly2descendants
- K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013 · 2 generations on1descendant
- K230211CranioXpandKLS-Martin L.P. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955640 | Lorenz Mandibular Distractor | Biomet, Inc. | 1996 | — |
| 0 (this device) | K992873 | Lorenz External Mandibular Distractor | Walter Lorenz Surgical, Inc. | 1999 | — |
| +1 | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| +1 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| +2 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| +3 | K230211 | CranioXpand | KLS-Martin L.P. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K955640 | Lorenz Mandibular DistractorSummary page 1Summary of Safety and Effectiveness Device Name: Lorenz External Mandibular Distractor Predicate Device: Lorenz Mandibular Distractor, 510(k) number K955640 Classification Name: External Mandibular Fixator and/or Distractor Device Product Code and Regulation Number: MQN, 21 CFR .872'4… | 1996 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K034027 (KLS-Martin L.P., 2004) has gone furthest, with 3 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 | — |
What is it indicated for?
The Lorenz External Mandibular Distractor is an external fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.
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/K992873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992873: Lorenz External 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/K992873
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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