# K020448: Static Cranioplasty Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Eastern Cranial Affiliates
- Decided: Apr 12, 2002 after 60 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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
- K180568: KidCap (2018), 1 descendant of its own
- K193383: SnugKap (2021), 0 descendants of its own

## Indications for use
The Cranial Molding Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from three to 18 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

Source page: https://510kreport.com/device/K020448
Methodology: https://510kreport.com/methodology