510(k) · Cleared
ClearedCraniotech Bone Transport Reconstruction Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Scientific · MQN External Mandibular Fixator And/Or Distractor
Cleared on May 11, 2007 as substantially equivalent to K010139 (KLS-Martin L.P., 2001) after a 253-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 11, 2007
- Review
- 253 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010139 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010139 Zurich Distraction SystemKLS-Martin L.P. · 2001
- This deviceK062572 Craniotech Bone Transport Reconstruction PlateCustom Scientific · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010139 | Zurich Distraction System | KLS-Martin L.P. | 2001 | — |
| 0 (this device) | K062572 | Craniotech Bone Transport Reconstruction Plate | Custom Scientific | 2007 | — |
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 |
|---|---|---|---|
| * | K010139 | Zurich Distraction SystemSummary page 1…ibular Fixator and/or Distractor Classification Number: 21 CFR 872.4760 Classification Name: Bone Plate Product Code: MQN Predicate Device: K010139; Zurich Distraction System; KLS-Martin L.P. Statement of Intended The Craniotech Bone Transport Reconstruction Plate (BTRP… | 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?
- Its one ancestor has no recall.
- 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. 2007, 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?
The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended
as a bone stabilizer, lengthening and/or transport device when correction of congenital or
developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible
(including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062572: Craniotech Bone Transport Reconstruction Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062572
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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