510(k) · Cleared
ClearedSurgisis Nerve Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · JXI Cuff, Nerve
Cleared on May 15, 2003 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 3 other predicates after a 41-day review. Its family tree reaches back 3 generations to 1992. 10 later devices descend from it.
- Decided
- May 15, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K921895 (1992). 10 ancestors in all, the oldest K830889 (1983). 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
- This deviceK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK132660 Nerve CuffCook Biotech Incorporated · 2014
- Descendant · 2 generations on · 2 of its ownK223640 Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
- Descendant · cites it directly · 2 of its ownK162741 AxoGuard Nerve ConnectorCook Biotech Incorporated · 2016
- Descendant · 2 generations on · 1 of its ownK210665 Nerve TapeBiocircuit Technologies, Incorporated · 2022
- Descendant · cites it directly · 1 of its ownK130557 Neuragen 3DIntegra LifeSciences Corporation · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132660Nerve CuffCook Biotech Incorporated · 2014 · cites it directly6descendants
- K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation · 2023 · 2 generations on2descendants
- K162741AxoGuard Nerve ConnectorCook Biotech Incorporated · 2016 · cites it directly2descendants
- K210665Nerve TapeBiocircuit Technologies, Incorporated · 2022 · 2 generations on1descendant
- K130557Neuragen 3DIntegra LifeSciences Corporation · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| 0 (this device) | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
| +1 | K132660 | Nerve Cuff | Cook Biotech Incorporated | 2014 | — |
| +2 | K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22)… | Axogen Corporation | 2023 | — |
| +1 | K162741 | AxoGuard Nerve Connector | Cook Biotech Incorporated | 2016 | — |
| +2 | K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | 2022 | — |
| +1 | K130557 | Neuragen 3D | Integra LifeSciences Corporation | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 1…~ Nerve Cuff is similar to predicate devices, including the SURGISIS~ Soft Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, the NeuroGen Nerve Guide (KO1 1168) manufactured by Integra Life Sciences, the SaluBr… | 1998 |
| * | K011168 | Neurogen Nerve Guide | 2001 |
| * | K002098 | Salumedica Nerve CuffSummary page 1…Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, the NeuroGen Nerve Guide (KO1 1168) manufactured by Integra Life Sciences, the SaluBridge Nerve Cuff (K002098) manufactured by Salumedica, LLC, and the Collagen Nerve Cuff (KO128 14) manufactured by Collagen Matrix Incorporated. Device De… | 2000 |
| * | K012814 | Collagen Nerve Cuff | 2001 |
What descends from it? (10)
3 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K132660 (Cook Biotech Incorporated, 2014) has gone furthest, with 6 descendants of its own.
- 28 other devices also cite its predicate K980431.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The SURGISIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031069 · printed Nov 3, 2026
Cite this page
510(k) Report. “K031069: Surgisis Nerve Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031069
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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