510(k) · Cleared
Recalled · Class II · 2013Neura Wrap Nerve Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · JXI Cuff, Nerve
Cleared on Jul 16, 2004 after a 30-day review. The FDA summary names its predicate without a number. 52 later devices descend from it. It has been recalled once.
- Decided
- Jul 16, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- JXI
- Recalls
- 1
- Predicates
- 0
52 later devices descend from it, 6 citing it directly.
- This deviceK041620 Neura Wrap Nerve ProtectorIntegra Lifesciences Corp. · 2004
- Descendant · cites it directly · 39 of its ownK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- Descendant · cites it directly · 22 of its ownK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- Descendant · 2 generations on · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 3 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · 2 generations on · 13 of its ownK061473 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · Recalled
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K053655Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006 · cites it directly39descendants
- K060952Collagen Nerve WrapCollagen Matrix, Inc. · 2006 · cites it directly22descendants
- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · 2 generations on15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 3 generations on14descendants
- K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041620 | Neura Wrap Nerve Protector | Integra Lifesciences Corp. | 2004 | — |
| +1 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| +1 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| +2 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +3 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +2 | K061473 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 11 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | NeuraGen Nerve Guide Named without a submission number | |
| * | — | Fastube Nerve Cuff Named without a submission number |
What descends from it? (52)
See all 526 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053655 | Tendon Wrap Tendon Protector | 2006 | 39 |
| K060952 | Collagen Nerve Wrap | 2006 | 22 |
| K201631 | VersaWrap Nerve Protector | 2020 | 3 |
| K103081 | Covaortho-Nerve Resorbable Collagen Membrane | 2012 | 3 |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40… | 2025 | 0 |
| K100382 | Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1286-2013 | Process control | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053655 (Integra LifeSciences Corporation, 2006) has gone furthest, with 39 descendants of its own.
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?
NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041620: Neura Wrap Nerve Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041620
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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