# K220681: Talee, Talee PostOP

- Pathway: 510(k) (Traditional)
- Applicant: Invent Medical USA, LLC
- Decided: Sep 22, 2022 after 198 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: 11 generations back to K001167 (2000). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151979: STARband, STARlight, Orthomerica Products, Inc. (2015) Summary page 4.

## Most influential descendants
- K230444: Talee, Talee PostOp (2023), 1 descendant of its own
- K241957: Talee, Talee PostOp (2024), 0 descendants of its own

## Indications for use
The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities. The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects. The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.

Source page: https://510kreport.com/device/K220681
Methodology: https://510kreport.com/methodology