# K121304: Osteomed Cranial Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: Aug 22, 2012 after 113 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 K003883 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003883: Molina Orbital Malar Distractor, KLS-Martin L.P. (2001) Summary page 1.

## Most influential descendants
- K123885: Osteomed Smartflex Cranial Spring Distractor (2013), 1 descendant of its own
- K230211: CranioXpand (2023), 0 descendants of its own

## Indications for use
The OsteoMed Cranial 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 Cranial Distraction System implants are intended for single use only.

Source page: https://510kreport.com/device/K121304
Methodology: https://510kreport.com/methodology