510(k) · Cleared
ClearedInternal Distraction - Sterile
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 Dec 1, 2016 as substantially equivalent to K010139 (KLS-Martin L.P., 2001) and 7 other predicates after a 188-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.
- Decided
- Dec 1, 2016
- Review
- 188 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K792561 (1979). 10 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 backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- 1 generation backK983515 KLS Intraoral Vertical DistractorKLS-Martin L.P. · 1998
- This deviceK161470 Internal Distraction - SterileKLS Martin L.P. · 2016
- Descendant · cites it directly · 0 of its ownK220050 KLS Martin IPS DistractionKLS Martin L.P. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220050KLS Martin IPS DistractionKLS Martin L.P. · 2022 · 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 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| −1 | K983515 | KLS Intraoral Vertical Distractor | KLS-Martin L.P. | 1998 | — |
| 0 (this device) | K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (8)
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 |
|---|---|---|---|
| * | K010139 | Zurich Distraction SystemSummary page 4…bular Fixator And/or Distractor Class II, 21 CFR 872.4760, Product Code MQN Predicate Devices: Zurich Distraction System (K010139) (Primary Predicate) KLS Martin Intraoral Distractor (K973275)… | 2001 |
| * | K973275 | KLS-Martin Intraoral DistractorSummary page 4…duct Code MQN Predicate Devices: Zurich Distraction System (K010139) (Primary Predicate) KLS Martin Intraoral Distractor (K973275) KLS Intra-oral Vertical Distractor (K983515) KLS Martin Intrao… | 1997 |
| * | K983515 | KLS Intraoral Vertical DistractorSummary page 4…0139) (Primary Predicate) KLS Martin Intraoral Distractor (K973275) KLS Intra-oral Vertical Distractor (K983515) KLS Martin Intraoral Zurich Ramus Distractor (K983809) K-L-W I… | 1998 |
| * | K983809 | KLS Martin Intraoral Zurich Ramus DistractorSummary page 4…or (K973275) KLS Intra-oral Vertical Distractor (K983515) KLS Martin Intraoral Zurich Ramus Distractor (K983809) K-L-W Intraoral Distractor (K991875) Zurich Pediatric Maxillar… | 1999 |
| * | K991875 | K-L-W Intraoral DistractorSummary page 4…Distractor (K983515) KLS Martin Intraoral Zurich Ramus Distractor (K983809) K-L-W Intraoral Distractor (K991875) Zurich Pediatric Maxillary Distractor (K000580) Track 1.0 & 1.… | 1999 |
| * | K000580 | Zurich Pediatric Maxillary Distractor, Models 51-550-15 and 51-551-15Summary page 4…Ramus Distractor (K983809) K-L-W Intraoral Distractor (K991875) Zurich Pediatric Maxillary Distractor (K000580) Track 1.0 & 1.5 mm Systems – Tissue Regeneration by Alveolar C… | 2000 |
| * | K002152 | Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus DistractionSummary page 4…y Distractor (K000580) Track 1.0 & 1.5 mm Systems – Tissue Regeneration by Alveolar Callus Distraction (K002152) Molina Orbital Malar Distractor (K003883) Device Description Internal Distraction - Sterile co… | 2000 |
| * | K003883 | Molina Orbital Malar DistractorSummary page 4…Systems – Tissue Regeneration by Alveolar Callus Distraction (K002152) Molina Orbital Malar Distractor (K003883) Device Description Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction… | 2001 |
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 |
|---|---|---|---|
| K220050 | KLS Martin IPS Distraction | 2022 | 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 37 years and passes through 4 companies; a new generation was cleared every 16.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K220050 (KLS Martin L.P., 2022) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K010139.
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. 2016, 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?
Internal Distraction - Sterile 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, symphysis) and mid-face bones that require gradual distraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161470: Internal Distraction - Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161470
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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