# K022273: Cranial Symmetry System

- Pathway: 510(k) (Traditional)
- Applicant: Beverly Hills Prosthetics Orthotics, Inc.
- Decided: Sep 9, 2002 after 56 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: 1 generation back to K003035 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003035: Clarren Helmet, Children'S Hospital & Medical Center (2001) Summary page 2.

## Indications for use
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants’ 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads. The sale and distribution of the device is restricted to prescription use in accordance with 21 CFR 801.109

Source page: https://510kreport.com/device/K022273
Methodology: https://510kreport.com/methodology