# K163315: Internal Distraction - Sterile

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: May 5, 2017 after 163 days
- Product code: PBJ (Cranial Distraction System)
- Device class: 2
- Regulation: 21 CFR 882.5330
- 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 4.

## Indications for use
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 cranial bones that require gradual distraction.

Source page: https://510kreport.com/device/K163315
Methodology: https://510kreport.com/methodology