510(k) · Cleared
ClearedVersaWrap Nerve Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alafair Biosciences, Inc. · JXI Cuff, Nerve
Cleared on Sep 14, 2020 as substantially equivalent to K041620 (Integra Lifesciences Corp., 2004) after a 90-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it.
- Decided
- Sep 14, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041620 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK041620 Neura Wrap Nerve ProtectorIntegra Lifesciences Corp. · 2004 · Recalled
- This deviceK201631 VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK232029 VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK251505 VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector…Alafair Biosciences · 2025
- Descendant · 2 generations on · 0 of its ownK251175 VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector…Alafair Biosciences · 2025
Most influential descendants
Showing 3 of 3 · See all- K232029VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2023 · cites it directly2descendants
- K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair Biosciences · 2025 · 2 generations on0descendants
- K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair Biosciences · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041620 | Neura Wrap Nerve Protector | Integra Lifesciences Corp. | 2004 | 1 |
| 0 (this device) | K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020 | — |
| +1 | K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023 | — |
| +2 | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | 2025 | — |
| +2 | K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K041620 | Neura Wrap Nerve ProtectorSummary page 4…tor Common Name Cuff, Nerve Classification number 21 CFR 882.5275 Product Code JXI Primary Predicate: Integra NeuraWrap Nerve Protector K041620 Reference Device: Alafair VersaWrap Tendon Protector K200311 VersaWrap Nerve Protector (VersaWrap… | 2004 |
| † | K200311 | VersaWrap Tendon Protector | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232029 | VersaWrap Nerve Protector | 2023 | 2 |
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?
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
VersaWrap 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/K201631 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201631: VersaWrap Nerve Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201631
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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