510(k) · Cleared
ClearedNervAlign Nerve Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renerve, Ltd. · JXI Cuff, Nerve
Cleared on Feb 10, 2022 as substantially equivalent to K132660 (Cook Biotech Incorporated, 2014) after a 552-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Feb 10, 2022
- Review
- 552 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921895 (1992). 12 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
- 1 generation backK132660 Nerve CuffCook Biotech Incorporated · 2014
- This deviceK202234 NervAlign Nerve CuffRenerve, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
| −1 | K132660 | Nerve Cuff | Cook Biotech Incorporated | 2014 | — |
| 0 (this device) | K202234 | NervAlign Nerve Cuff | Renerve, Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K132660 | Nerve CuffSummary page 4…21 CFR 882.5275 Product Code JXI Regulatory Class II Predicate Device Name [510(k) Number] AxoGuard Nerve Protector [K132660] Device Description The NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, w… | 2014 |
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 30 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K132660.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202234: NervAlign Nerve Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202234
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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