# K223640: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

- Pathway: 510(k) (Traditional)
- Applicant: Axogen Corporation
- Decided: Apr 7, 2023 after 123 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921895 (1992). 12 ancestors in all.
2 later devices descend from it; 2 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)
- K132660: Nerve Cuff, Cook Biotech Incorporated (2014) Summary page 4.

## Most influential descendants
- K242113: Nerve Wrap (07-DW-001-TAB) (2025), 0 descendants of its own
- K231708: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (2023), 0 descendants of its own

## Indications for use
Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where there is no gap.

Source page: https://510kreport.com/device/K223640
Methodology: https://510kreport.com/methodology