# K063133: Cranial Solution Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Cranial Solutions
- Decided: Jul 2, 2007 after 262 days
- Product code: MVA (Orthosis, Cranial)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dynamic Orthotic Cranioplasty (DOC): named in the summary without a submission number

## Indications for use
The Cranial Solutions Orthosis is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.

Source page: https://510kreport.com/device/K063133
Methodology: https://510kreport.com/methodology