# K111609: Boston Band

- Pathway: 510(k) (Traditional)
- Applicant: Boston Brace Intl., Inc.
- Decided: Aug 22, 2011 after 74 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). 9 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 26 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.
- K072862: Boston-Band Cranial Remodling Orthosis, Boston Brace Intl., Inc. (2008) Summary page 1.
- K072566: Hanger Cranial Band, Hanger Prosthetics & Orthotics, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K151147: STARband, STARlight (2015), 9 descendants of its own

## Indications for use
The Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K111609
Methodology: https://510kreport.com/methodology