# K062572: Craniotech Bone Transport Reconstruction Plate

- Pathway: 510(k) (Traditional)
- Applicant: Custom Scientific
- Decided: May 11, 2007 after 253 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010139 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K062572
Methodology: https://510kreport.com/methodology