510(k) · Cleared
ClearedRebuilder Nerve Guidance Conduit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celestray Biotech Company, LLC., · JXI Cuff, Nerve
Cleared on Jan 29, 2024 as substantially equivalent to K112267 (Polyganics B.V.,, 2011) and 1 other predicate after a 313-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jan 29, 2024
- Review
- 313 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K983007 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK983007 NeurotubeNeuroregen, LLC · 1999 · Recalled
- 2 generations backK032115 Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03…Polyganics B.V., · 2003
- 1 generation backK050573 Neurolac Nerve GuidePolyganics B.V., · 2005
- This deviceK230794 Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC., · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983007 | Neurotube | Neuroregen, LLC | 1999 | 1 |
| −2 | K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | Polyganics B.V., | 2003 | — |
| −1 | K050573 | Neurolac Nerve Guide | Polyganics B.V., | 2005 | — |
| 0 (this device) | K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K112267 | Neurolac (R) Nerve GuideSummary page 5…lass II JXI Legally Marketed Devices to Which Substantial Equivalence is Claimed Primary Predicate Device Neurolac Nerve guide, K112267 Polyganics BV. Additional Predicate Device Neurolac Nerve guide, K050573… | 2011 |
| * | K050573 | Neurolac Nerve GuideSummary page 5…aimed Primary Predicate Device Neurolac Nerve guide, K112267 Polyganics BV. Additional Predicate Device Neurolac Nerve guide, K050573 Polyganics BV. Reference Device NeuroGen Nerve Guide, K011168… | 2005 |
| † | K011168 | Neurogen Nerve Guide | 2001 |
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 25 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K112267.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230794: Rebuilder Nerve Guidance Conduit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230794
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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