# K111247: Cranial Remolding Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Orthotic Care Services, Llp
- Decided: Aug 15, 2011 after 104 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
Longest line of descent: 4 generations back to K001167 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082950: Starband, Orthomerica Products, Inc. (2008) Summary page 1.
- K011350: Starband Cranial Orthosis, Orthomerica Products, Inc. (2001) Summary page 1.

## Indications for use
The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads, by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K111247
Methodology: https://510kreport.com/methodology