510(k) · Cleared
ClearedLorenz Maxilla (LE Fort) 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 Oct 23, 1998 as substantially equivalent to K972166 (Howmedica Leibinger, Inc., 1997) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.
- Decided
- Oct 23, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K792561 (1979). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 2 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 1 generation backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- This deviceK982604 Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK031708 Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP · 2003
Most influential descendants
Showing 1 of 1 · See all- K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −3 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −2 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K982604 | Lorenz Maxilla (LE Fort) Distraction System | Walter Lorenz Surgical, Inc. | 1998 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 | Decided |
|---|---|---|---|
| * | K972166 | Guerrero - Bell DistractorSummary page 1…pping, or fracture of implant Substantially Equivalent Devices: The device is believed to be substantially equivalent to Howmedica Leibinger’s Guerrero-Bell Distractor (K972166), and Cohen Distractor (K972154), and Synthes Mini Lengthening Apparatus (K973018) DEPARTMENT OF HEALTH & HUMAN S… | 1997 |
| * | K972154 | Cohen DistractorSummary page 1…ubstantially Equivalent Devices: The device is believed to be substantially equivalent to Howmedica Leibinger’s Guerrero-Bell Distractor (K972166), and Cohen Distractor (K972154), and Synthes Mini Lengthening Apparatus (K973018) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service F… | 1997 |
| * | K973018 | Synthes Mini Lengthening ApparatusSummary page 1…ieved to be substantially equivalent to Howmedica Leibinger’s Guerrero-Bell Distractor (K972166), and Cohen Distractor (K972154), and Synthes Mini Lengthening Apparatus (K973018) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Bouleva… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031708 | Osteomed Maxillary/Lefort Iii Distraction System | 2003 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K031708 (Osteomed LP, 2003) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972166.
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 Maxilla (Le Fort) Distraction System is intended for use in the maxilla as a bone stabilizer and lengthening device when correction of congenital midfacial deficiencies or post traumatic defects require gradual bone 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/K982604 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982604: Lorenz Maxilla (LE Fort) Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982604
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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