510(k) · Cleared
ClearedLorenz Distraction System
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 Nov 19, 1999 after a 79-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Nov 19, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK992952 Lorenz Distraction SystemWalter Lorenz Surgical, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK030425 Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK133304 RXG Distraction SystemKLS-Martin L.P. · 2014
- Descendant · cites it directly · 0 of its ownK030790 Osteomed Alveolar Distraction SystemOsteomed LP · 2003
- Descendant · cites it directly · 0 of its ownK020407 Lorenz Blue DeviceWalter Lorenz Surgical, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K030425Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004 · cites it directly1descendant
- K133304RXG Distraction SystemKLS-Martin L.P. · 2014 · 2 generations on0descendants
- K030790Osteomed Alveolar Distraction SystemOsteomed LP · 2003 · cites it directly0descendants
- K020407Lorenz Blue DeviceWalter Lorenz Surgical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992952 | Lorenz Distraction System | Walter Lorenz Surgical, Inc. | 1999 | — |
| +1 | K030425 | Lorenz Resorbable Distraction System or Expander | Walter Lorenz Surgical, Inc. | 2004 | — |
| +2 | K133304 | RXG Distraction System | KLS-Martin L.P. | 2014 | — |
| +1 | K030790 | Osteomed Alveolar Distraction System | Osteomed LP | 2003 | — |
| +1 | K020407 | Lorenz Blue Device | Walter Lorenz Surgical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
3 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?
- Of its descendants, K030425 (Walter Lorenz Surgical, Inc., 2004) has gone furthest, with 1 descendant 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 Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
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/K992952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992952: Lorenz Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992952
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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