# K161138: St. Louis Band

- Pathway: 510(k) (Traditional)
- Applicant: Orthomerica Products, Inc.
- Decided: Jul 20, 2016 after 89 days
- Product code: OAN (Orthosis, Cranial, Laser Scan)
- 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: 11 generations back to K001167 (2000). 21 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063395: O&P Bivalve Cranial Molding Helmet, Orthotic & Prosthetic Lab, Inc. (2006) Summary page 5.
- K151979: STARband, STARlight, Orthomerica Products, Inc. (2015) Summary page 5.

## Most influential descendants
- 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
- K201426: MyCRO Band (2021), 0 descendants of its own

## Indications for use
The St. Louis Band is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K161138
Methodology: https://510kreport.com/methodology