# K230211: CranioXpand

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Nov 21, 2023 after 299 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: 6 generations back to K864403 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123885: Osteomed Smartflex Cranial Spring Distractor, Osteomed LP (2013) Summary page 5.

## Indications for use
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days to < 2 years of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization and distraction of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.

Source page: https://510kreport.com/device/K230211
Methodology: https://510kreport.com/methodology