# K013719: Becker Band Cranial Remolding Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Becker Orthopedic Appliance Co.
- Decided: Feb 5, 2002 after 89 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 DEN980001 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band, Cranial Technologies, Inc. (1998). Our OCR of the scanned summary read K964992, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980001, Dynamic Orthotic Cranioplasty Band; Doc Band (Cranial Technologies, Inc.), granted May 29, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K001167: Opi Band, Orthomerica Products, Inc. (2000) Summary page 1.
- K000861: Craniocap, Gillette Children'S Specialty Healthcare (2000) Summary page 1.
- K010273: Cranial Molding Orthosis, Orthotic Solutions, Inc. (2001) Summary page 1.
- (no number) Cranial Orthosis: named in the summary without a submission number

## Indications for use
Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. Contraindications for use: Infants with synostosis or hydrocephalus.

Source page: https://510kreport.com/device/K013719
Methodology: https://510kreport.com/methodology