# K063098: Static Cranioplasty Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Brace Intl., Inc.
- Decided: Apr 11, 2007 after 183 days
- Product code: OAN (Orthosis, Cranial, Laser Scan)
- Device class: 2
- Regulation: 21 CFR 882.5970
- 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 K011350 (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)
- K011350: Starband Cranial Orthosis, Orthomerica Products, Inc. (2001) Summary page 4.

## Indications for use
Infants, 3 - 18 months of age, with abnormally shaped craniums with no outstanding cranial abnormalities that have a RX from a physician who has assessed the child to rule out craniosynostosis.

Source page: https://510kreport.com/device/K063098
Methodology: https://510kreport.com/methodology