510(k) · Cleared
ClearedNeurolac Nerve Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polyganics B.V., · JXI Cuff, Nerve
Cleared on May 4, 2005 as substantially equivalent to K002098 (Salumedica, LLC, 2000) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K983007 (1999). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983007 NeurotubeNeuroregen, LLC · 1999 · Recalled
- 1 generation backK032115 Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03…Polyganics B.V., · 2003
- This deviceK050573 Neurolac Nerve GuidePolyganics B.V., · 2005
- Descendant · cites it directly · 0 of its ownK230794 Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC., · 2024
- Descendant · cites it directly · 0 of its ownK152684 Nerve Capping DevicePolyganics Innovations BV · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983007 | Neurotube | Neuroregen, LLC | 1999 | 1 |
| −1 | K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | Polyganics B.V., | 2003 | — |
| 0 (this device) | K050573 | Neurolac Nerve Guide | Polyganics B.V., | 2005 | — |
| +1 | K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | 2024 | — |
| +1 | K152684 | Nerve Capping Device | Polyganics Innovations BV | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K002098 | Salumedica Nerve CuffSummary page 1…882.5275 Device Classification: Class II T Predicate Salumedica M nerve cuff, Salumedica, K002098 Devices Neurogen T M nerve guide, Integra life science, K011168… | 2000 |
| * | K011168 | Neurogen Nerve GuideSummary page 1…Salumedica M nerve cuff, Salumedica, K002098 Devices Neurogen T M nerve guide, Integra life science, K011168 Neurolac® nerve guide, Polyganics BV, K032115 Performance For the Nerve Cuff performance, t… | 2001 |
| * | K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03Summary page 1…Neurogen T M nerve guide, Integra life science, K011168 Neurolac® nerve guide, Polyganics BV, K032115 Performance For the Nerve Cuff performance, the FDA, under section 514 of the Food, Standards Drug and Cosm… | 2003 |
What descends from it? (2)
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)
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 6 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K230794 (Celestray Biotech Company, LLC.,, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K002098.
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 Neurolac nerve guide 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/K050573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050573: Neurolac 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/K050573
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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