# K090341: Michigan Cranial Reshaping Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Danmar Products, Inc.
- Decided: Jan 6, 2010 after 330 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: 3 generations back to DEN980001 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072566: Hanger Cranial Band, Hanger Prosthetics & Orthotics, Inc. (2008) Summary page 1.
- K072862: Boston-Band Cranial Remodling Orthosis, Boston Brace Intl., Inc. (2008) Summary page 1.
- K003630: Danmar Products Michigan Cranial Helmet, Danmar Products, Inc. (2001) Summary page 1.

## Indications for use
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

Source page: https://510kreport.com/device/K090341
Methodology: https://510kreport.com/methodology