# K173571: Element System with IBT Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Infinite Biomedical Technologies, LLC
- Decided: Mar 21, 2018 after 121 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032833 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123795: Axon-Bus Prosthetic System, Otto Bock Austria (2014) Summary page 4.

## Indications for use
The Element system is intended to be used exclusively for myoelectric exoprosthetic fittings of the upper limb.

Source page: https://510kreport.com/device/K173571
Methodology: https://510kreport.com/methodology