510(k) · Cleared
ClearedNeuragen 3D
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 Apr 24, 2014 as substantially equivalent to K011168 (Integra Lifesciences Corp., 2001) and 3 other predicates after a 416-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Apr 24, 2014
- Review
- 416 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K881854 (1988). 21 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 3 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 1 generation backK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
- This deviceK130557 Neuragen 3DIntegra LifeSciences Corporation · 2014
- Descendant · cites it directly · 0 of its ownK163457 NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −3 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −1 | K022127 | Avagen Wound Dressing | Integra Lifesciences Corp. | 2002 | — |
| 0 (this device) | K130557 | Neuragen 3D | Integra LifeSciences Corporation | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K011168 | Neurogen Nerve GuideSummary page 6…UNIT UNCERTAINTY U Conclusion: The NeuraGenO 3D is substantially equivalent to the commercially marketed device, NeuraGen® Nerve Guide (1(011168). Additional predicate devices to which this device demonstrates substantial equivalence include the Cook Biotech Surgisis® Nerve… | 2001 |
| * | K031069 | Surgisis Nerve CuffSummary page 6…NeuraGen® Nerve Guide (1(011168). Additional predicate devices to which this device demonstrates substantial equivalence include the Cook Biotech Surgisis® Nerve Cuff (K(031069) the SaluMedica TM Nerve Cuff (1(002098), and Avagen Wound Dressing (K022127). The design expressed in this 510(k) Premarket Not… | 2003 |
| * | K002098 | Salumedica Nerve CuffSummary page 1…SugissO Nrve uff Cook Biotech K03169 JI Sugiss® Nrve uff Incorporated K(002098 JXI SaluMedica Cuff TmNerve SaluMedica TmL.… | 2000 |
| * | K022127 | Avagen Wound DressingSummary page 6…device demonstrates substantial equivalence include the Cook Biotech Surgisis® Nerve Cuff (K(031069) the SaluMedica TM Nerve Cuff (1(002098), and Avagen Wound Dressing (K022127). The design expressed in this 510(k) Premarket Notification does not change the indications for use, intended use, or fundament… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163457 | NeuraGen 3D Nerve Guide Matrix | 2017 | 0 |
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 26 years and passes through 5 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K163457 (Integra LifeSciences Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K011168.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
NeuraGen® 3D is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
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/K130557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130557: Neuragen 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130557
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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