# K013700: Orthosis Helmet Molding

- Pathway: 510(k) (Traditional)
- Applicant: Precision Prosthetics & Orthotics, Inc.
- 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). 1 ancestor in all.
6 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)
- 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.

## Most influential descendants
- K063395: O&P Bivalve Cranial Molding Helmet (2006), 5 descendants of its own
- K161138: St. Louis Band (2016), 4 descendants of its own
- K180109: STARband, STARlight, St. Louis Band (2018), 3 descendants of its own
- K213587: MyCRO Band (2022), 0 descendants of its own
- K193383: SnugKap (2021), 0 descendants of its own

## Indications for use
The Precision Prosthetics and Orthotics, Inc. orthotic molding helmet is intended to apply passive pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K013700
Methodology: https://510kreport.com/methodology