# K081787: Camlab Cranial Orthosis Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Biosculptor Corporation
- Decided: Jan 27, 2009 after 217 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.
16 later devices descend from it; 1 cites it directly.
0 of 18 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). Our reading of the summary gave K001350, FDA’s number for Patient Matched Titanium Alloy Trochlea (Biomet, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Orthomerica STARband”.

## 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 CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.

Source page: https://510kreport.com/device/K081787
Methodology: https://510kreport.com/methodology