510(k) · Cleared
ClearedSILKBridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLISBio S.r.l. · JXI Cuff, Nerve
Cleared on Apr 9, 2026 as substantially equivalent to K112267 (Polyganics B.V.,, 2011) after a 72-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Apr 9, 2026
- Review
- 72 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983007 (1999). 4 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 backK112267 Neurolac (R) Nerve GuidePolyganics B.V., · 2011
- This deviceK260245 SILKBridgeKLISBio S.r.l. · 2026
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 | K112267 | Neurolac (R) Nerve Guide | Polyganics B.V., | 2011 | — |
| 0 (this device) | K260245 | SILKBridge | KLISBio S.r.l. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K112267 | Neurolac (R) Nerve GuideSummary page 5…rve Cuff Classification name: Cuff, Nerve Regulation number: 882.5275 Product code: JXI Regulatory class: II 3. PREDICATE DEVICE Predicate 510(k) number: K112267 Predicate trade name: NEUROLAC® TW NERVE GUIDE Product code: JXI 4. DEVICE DESCRIPTION SUMMARY SILKBridge® Biointegrative… | 2011 |
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 27 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 4 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. 2026, 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?
SILKBridge is indicated for the surgical repair of peripheral nerve discontinuities of up to 10 mm.
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/K260245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260245: SILKBridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260245
Report an extraction error
Are you the manufacturer?
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