510(k) · Cleared
ClearedAxoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axogen Corporation · JXI Cuff, Nerve
Cleared on Oct 12, 2023 as substantially equivalent to K223640 (Axogen Corporation, 2023) after a 122-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Oct 12, 2023
- Review
- 122 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921895 (1992). 13 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
- 2 generations backK132660 Nerve CuffCook Biotech Incorporated · 2014
- 1 generation backK223640 Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
- This deviceK231708 Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
| −2 | K132660 | Nerve Cuff | Cook Biotech Incorporated | 2014 | — |
| −1 | K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22)… | Axogen Corporation | 2023 | — |
| 0 (this device) | K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22)… | Axogen Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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 JXI? 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 JXI device
- #1 K232029 VersaWrap Nerve Protectorscore 12.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Summary page 5…on Number: 3. Predicate Device Device Company Predicate 510(k) Clearance date Axoguard HA+ Axogen K223640 April 7, 2023 Nerve Protector 4. Device Description Axoguard HA+ Nerve Protector is a surgical implant that… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 1 other device also cites its predicate K223640.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXI
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXI
No recall names JXI since 2007.
Adverse event reports per year · JXI
18in 2025
MAUDE reports naming product code JXI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 3 | 309 | 0 | 7 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 117 | 0 | 8 |
| 2017 | 3 | 90 | 0 | 9 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 3 | 122 | 0 | 15 |
| 2024 | 3 | 266 | 0 | 18 |
| 2025 | 4 | 99 | 0 | 18 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Axoguard HA+ Nerve Protector is indicated for the management and protection of peripheral nerve injuries where there is no gap, or following closure of the gap.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231708 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231708
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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