510(k) · Cleared
ClearedNeuraGen 3D Nerve Guide Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · JXI Cuff, Nerve
Cleared on Jan 6, 2017 as substantially equivalent to K130557 (Integra LifeSciences Corporation, 2014) after a 28-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Jan 6, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881854 (1988). 22 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 2 generations backK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
- 1 generation backK130557 Neuragen 3DIntegra LifeSciences Corporation · 2014
- This deviceK163457 NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −2 | K022127 | Avagen Wound Dressing | Integra Lifesciences Corp. | 2002 | — |
| −1 | K130557 | Neuragen 3D | Integra LifeSciences Corporation | 2014 | — |
| 0 (this device) | K163457 | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K130557 | Neuragen 3DSummary page 4…Trade Name Manufacturer Number Code Integra LifeSciences K130557 JXI NeuraGen® 3D Nerve Guide Corporation… | 2014 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 22 ancestors has a recall of any class.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163457 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163457: NeuraGen 3D Nerve Guide Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163457
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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