# K123885: Osteomed Smartflex Cranial Spring Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Jun 3, 2013 after 167 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: 5 generations back to K864403 (1986). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121304: Osteomed Cranial Distraction System, Osteomed (2012) Summary page 1.
- K003883: Molina Orbital Malar Distractor, KLS-Martin L.P. (2001) Summary page 3.
- K063792: Osteomed External Mandibular Distraction System, Osteomed LP (2007) Summary page 1.

## Most influential descendants
- K230211: CranioXpand (2023), 0 descendants of its own

## Indications for use
The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

Source page: https://510kreport.com/device/K123885
Methodology: https://510kreport.com/methodology