510(k) · Cleared
ClearedKLS Martin IPS Distraction
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 Aug 11, 2022 as substantially equivalent to K161470 (KLS Martin L.P., 2016) after a 217-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Aug 11, 2022
- Review
- 217 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K792561 (1979). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 4 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 3 generations backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- 2 generations backK983515 KLS Intraoral Vertical DistractorKLS-Martin L.P. · 1998
- 1 generation backK161470 Internal Distraction - SterileKLS Martin L.P. · 2016
- This deviceK220050 KLS Martin IPS DistractionKLS Martin L.P. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −4 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −3 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| −2 | K983515 | KLS Intraoral Vertical Distractor | KLS-Martin L.P. | 1998 | — |
| −1 | K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016 | — |
| 0 (this device) | K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K161470 | Internal Distraction - SterileSummary page 4…on Name: Bone Plate Regulatory Class: II Product Code: MQN Primary Predicate: KLS Martin Internal Distraction – Sterile (K161470) Reference Devices: KLS Martin Individual Patient Solutions (K191028) KLS Martin Zurich… | 2016 |
| † | K191028 | KLS Martin Individual Patient Solutions | 2019 |
| † | K010139 | Zurich Distraction System | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 11 ancestors has a recall.
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. 2022, this device’s year, is highlighted.
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?
KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220050: KLS Martin IPS Distraction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220050
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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