510(k) · Cleared
ClearedKLS-Martin Intraoral Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Nov 20, 1997 as substantially equivalent to K962272 (Synthes (Usa), 1996) after a 79-day review. Its family tree reaches back 2 generations to 1979. 8 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K792561 (1979). 8 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 1 generation backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- This deviceK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- Descendant · cites it directly · 3 of its ownK991875 K-L-W Intraoral DistractorKLS-Martin L.P. · 1999
- Descendant · cites it directly · 3 of its ownK983515 KLS Intraoral Vertical DistractorKLS-Martin L.P. · 1998
- Descendant · cites it directly · 1 of its ownK161470 Internal Distraction - SterileKLS Martin L.P. · 2016
- Descendant · cites it directly · 1 of its ownK014001 Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Oral Osteodistraction, L.P. · 2003
- Descendant · 2 generations on · 0 of its ownK220050 KLS Martin IPS DistractionKLS Martin L.P. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K991875K-L-W Intraoral DistractorKLS-Martin L.P. · 1999 · cites it directly3descendants
- K983515KLS Intraoral Vertical DistractorKLS-Martin L.P. · 1998 · cites it directly3descendants
- K161470Internal Distraction - SterileKLS Martin L.P. · 2016 · cites it directly1descendant
- K014001Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Oral Osteodistraction, L.P. · 2003 · cites it directly1descendant
- K220050KLS Martin IPS DistractionKLS Martin L.P. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −1 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| 0 (this device) | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| +1 | K991875 | K-L-W Intraoral Distractor | KLS-Martin L.P. | 1999 | — |
| +1 | K983515 | KLS Intraoral Vertical Distractor | KLS-Martin L.P. | 1998 | — |
| +1 | K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016 | — |
| +1 | K014001 | Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3 | Oral Osteodistraction, L.P. | 2003 | — |
| +2 | K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K962272 | Synthes Mandible DistractorSummary page 1…ansom Date of Summary: August 26, 1997 Trade Name: KLS-Martin Intraoral Distractor Classification Name: Mandible Distractor Predicate Device: Synthes Mandible Distractor K962272 Device Description/ Comparison: The KLS-Martin Intraoral Distractor is a subcutaneous bone distractor. It features two telescop… | 1996 |
What descends from it? (8)
5 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K991875 (KLS-Martin L.P., 1999) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K962272.
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 KLS-Martin Intraoral Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. (Micrognathia, Hemifacial Microsomia, Congenital Craniofacial Syndromes)
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/K973275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973275: KLS-Martin Intraoral Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973275
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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