510(k) · Cleared
ClearedAxon-Bus Prosthetic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Austria · GXY Electrode, Cutaneous
Cleared on Jun 3, 2014 as substantially equivalent to K032833 (Otto Bock Healthcare LP, 2003) after a 540-day review. Its family tree reaches back 1 generation to 2003. 13 later devices descend from it.
- Decided
- Jun 3, 2014
- Review
- 540 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032833 (2003). 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK032833 Myosystem with CustomizingOtto Bock Healthcare LP · 2003
- This deviceK123795 Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
- Descendant · cites it directly · 7 of its ownK162891 Complete Control SystemCoapt, LLC · 2017
- Descendant · cites it directly · 3 of its ownK220002 Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 2022
- Descendant · 2 generations on · 3 of its ownK191083 COMPLETE CONTROL System Gen2Coapt, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK223738 Alpha Control Liner System (ACLS)Coapt · 2023
- Descendant · 2 generations on · 2 of its ownK182112 Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K162891Complete Control SystemCoapt, LLC · 2017 · cites it directly7descendants
- K220002Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 2022 · cites it directly3descendants
- K191083COMPLETE CONTROL System Gen2Coapt, LLC · 2019 · 2 generations on3descendants
- K223738Alpha Control Liner System (ACLS)Coapt · 2023 · 3 generations on2descendants
- K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032833 | Myosystem with Customizing | Otto Bock Healthcare LP | 2003 | — |
| 0 (this device) | K123795 | Axon-Bus Prosthetic System | Otto Bock Austria | 2014 | — |
| +1 | K162891 | Complete Control System | Coapt, LLC | 2017 | — |
| +1 | K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | 2022 | — |
| +2 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019 | — |
| +3 | K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 | — |
| +2 | K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032833 | Myosystem with CustomizingSummary page 1…Name: MyoSystem with Customizing Manufacturer: Otto Bock HealthCare Products GmbH * 510k Number: K032833 Date Cleared: June 3rd, 2010 Name: i-limb System Manufacturer:… | 2003 |
| * | — | i-limb System Named without a submission number | |
| * | — | Pro Hand System Named without a submission number | |
| * | — | Bebionic System Named without a submission number |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K162891 (Coapt, LLC, 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123795 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123795: Axon-Bus Prosthetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123795
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026