# K221859: Atalante

- Pathway: 510(k) (Traditional)
- Applicant: Wandercraft SAS
- Decided: Dec 29, 2022 after 185 days
- Product code: PHL (Powered Exoskeleton)
- Device class: 2
- Regulation: 21 CFR 890.3480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN130034 (2014). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173530: Indego (R), Parker-Hannifin Corporation (2018) Summary page 4.

## Most influential descendants
- K232077: Atalante X (2023), 2 descendants of its own
- K250904: Atalante X (2025), 1 descendant of its own
- K260381: Eve (2026), 0 descendants of its own

## Recalls of this device
- Apr 3, 2025 · Class II · Z-1739-2025: Potential for exoskeleton to lose lateral balance and cause patient to fall.

## Indications for use
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. The operator must complete a training program prior to use of the device. The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position. The device is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K221859
Methodology: https://510kreport.com/methodology