# K162891: Complete Control System

- Pathway: 510(k) (Traditional)
- Applicant: Coapt, LLC
- Decided: Apr 14, 2017 after 179 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.
7 later devices descend from it; 2 cite 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)
- K123795: Axon-Bus Prosthetic System, Otto Bock Austria (2014) Summary page 5.

## Most influential descendants
- K191083: COMPLETE CONTROL System Gen2 (2019), 3 descendants of its own
- K223738: Alpha Control Liner System (ACLS) (2023), 2 descendants of its own
- K182112: Sense System with IBT Electrodes (2018), 2 descendants of its own
- K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50) (2025), 1 descendant of its own
- K191179: Myo Plus (2019), 1 descendant of its own

## Indications for use
The Complete Control System is to be used exclusively for external prosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K162891
Methodology: https://510kreport.com/methodology