# K072862: Boston-Band Cranial Remodling Orthosis

- Pathway: 510(k) (Special)
- Applicant: Boston Brace Intl., Inc.
- Decided: Jan 22, 2008 after 109 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.
18 later devices descend from it; 3 cite it directly.
0 of 20 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 1.

## Most influential descendants
- K111609: Boston Band (2011), 16 descendants of its own
- K124023: Starband (2013), 15 descendants of its own
- K133250: Starlight (2014), 14 descendants of its own
- K140353: Starband and Starlight (2014), 13 descendants of its own
- K141842: Starband, Starlight (2014), 10 descendants of its own

## Indications for use
The Boston Band Cranial Molding Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.

Source page: https://510kreport.com/device/K072862
Methodology: https://510kreport.com/methodology