510(k) · Cleared
Recalled · Class II · 2023Neurotube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuroregen, LLC · JXI Cuff, Nerve
Cleared on Mar 22, 1999 after a 206-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 1999
- Review
- 206 days
- Class
- Class II
- Product code
- JXI
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK983007 NeurotubeNeuroregen, LLC · 1999
- Descendant · cites it directly · 5 of its ownK032115 Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03…Polyganics B.V., · 2003
- Descendant · 2 generations on · 3 of its ownK112267 Neurolac (R) Nerve GuidePolyganics B.V., · 2011
- Descendant · 2 generations on · 2 of its ownK050573 Neurolac Nerve GuidePolyganics B.V., · 2005
- Descendant · cites it directly · 1 of its ownK152967 NerbridgeToyobo Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK260245 SILKBridgeKLISBio S.r.l. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032115Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03Polyganics B.V., · 2003 · cites it directly5descendants
- K112267Neurolac (R) Nerve GuidePolyganics B.V., · 2011 · 2 generations on3descendants
- K050573Neurolac Nerve GuidePolyganics B.V., · 2005 · 2 generations on2descendants
- K152967NerbridgeToyobo Co., Ltd. · 2016 · cites it directly1descendant
- K260245SILKBridgeKLISBio S.r.l. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983007 | Neurotube | Neuroregen, LLC | 1999 | — |
| +1 | K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | Polyganics B.V., | 2003 | — |
| +2 | K112267 | Neurolac (R) Nerve Guide | Polyganics B.V., | 2011 | — |
| +2 | K050573 | Neurolac Nerve Guide | Polyganics B.V., | 2005 | — |
| +1 | K152967 | Nerbridge | Toyobo Co., Ltd. | 2016 | — |
| +3 | K260245 | SILKBridge | KLISBio S.r.l. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Silicone Nerve Cuffs Named without a submission number |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2023 | Class II | Z-1461-2023 | Under Investigation by firm | The product is brittle and potentially crumbling upon handling or when being removed from its package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032115 (Polyganics B.V.,, 2003) has gone furthest, with 5 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?
The Neurotube is intended for single use in patients with an injury to a peripheral nerve,
in which the nerve gap is more than or equal to 8 mm but less than or equal to 3 cm. The
nerve gap may be created primarily at the time of injury or created secondarily at the time
of exploration of failed primary repair.
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/K983007 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983007: Neurotube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983007
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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