510(k) · Cleared
Recalled · Class II · 2020Neurogen Nerve Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · JXI Cuff, Nerve
Cleared on Jun 22, 2001 after a 66-day review. The FDA summary names its predicate without a number. 46 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 22, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- JXI
- Recalls
- 2
- Predicates
- 0
46 later devices descend from it, 9 citing it directly.
- This deviceK011168 Neurogen Nerve GuideIntegra Lifesciences Corp. · 2001
- Descendant · cites it directly · 37 of its ownK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- Descendant · 2 generations on · 22 of its ownK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- Descendant · 3 generations on · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 4 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K012814Collagen Nerve CuffCollagen Matrix, Inc. · 2001 · cites it directly37descendants
- K060952Collagen Nerve WrapCollagen Matrix, Inc. · 2006 · 2 generations on22descendants
- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · 3 generations on15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 4 generations on14descendants
- K031069Surgisis Nerve CuffCook Biotech, Inc. · 2003 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011168 | Neurogen Nerve Guide | Integra Lifesciences Corp. | 2001 | — |
| +1 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| +2 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| +3 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +4 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +1 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | — | Salumedica™ Nerve Cuff Named without a submission number | |
| * | — | NeuroTube® Named without a submission number | |
| * | — | Fastube™ Nerve Cuff Named without a submission number |
What descends from it? (46)
See all 469 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012814 | Collagen Nerve Cuff | 2001 | 37 |
| K031069 | Surgisis Nerve Cuff | 2003 | 10 |
| K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | 2003 | 5 |
| K103081 | Covaortho-Nerve Resorbable Collagen Membrane | 2012 | 3 |
| K050573 | Neurolac Nerve Guide | 2005 | 2 |
| K143711 | Reaxon Plus | 2015 | 1 |
| K130557 | Neuragen 3D | 2014 | 1 |
| K253363 | NeuroSpan Bridge | 2026 | 0 |
| K180222 | Reaxon Plus | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2020 | Class III | Z-1470-2020 | Labeling mix-ups | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. |
| Mar 28, 2013 | Class II | Z-1287-2013 | Process control | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012814 (Collagen Matrix, Inc., 2001) has gone furthest, with 37 descendants of its own.
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?
NeuroGen™ Nerve Guide is indicated for repair of peripheral nerve discontinuities
where gap closure can be 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/K011168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011168: Neurogen Nerve Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011168
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026