# K211376: STARband

- Pathway: 510(k) (Special)
- Applicant: Orthomerica Products, Inc.
- Decided: Aug 17, 2021 after 105 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: 4 generations back to K001167 (2000). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K223238: STARband 3D (2023), 1 descendant of its own
- K240466: STARband 3D (2024), 0 descendants of its own

## Indications for use
The STARband is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. 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 will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.

Source page: https://510kreport.com/device/K211376
Methodology: https://510kreport.com/methodology