# K123795: Axon-Bus Prosthetic System

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Austria
- Decided: Jun 3, 2014 after 540 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: 1 generation back to K032833 (2003). 1 ancestor in all.
13 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032833: Myosystem with Customizing, Otto Bock Healthcare LP (2003) Summary page 1.
- (no number) i-limb System: named in the summary without a submission number
- (no number) Pro Hand System: named in the summary without a submission number
- (no number) Bebionic System: named in the summary without a submission number

## Most influential descendants
- K162891: Complete Control System (2017), 7 descendants of its own
- K220002: Dexus Prosthetics System (Model: MSL1, MSR1) (2022), 3 descendants of its own
- 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

## Indications for use
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K123795
Methodology: https://510kreport.com/methodology