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 Nov 2, 2023 as substantially equivalent to K201631 (Alafair Biosciences, Inc., 2020) after a 118-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Nov 2, 2023
- Review
- 118 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041620 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK041620 Neura Wrap Nerve ProtectorIntegra Lifesciences Corp. · 2004 · Recalled
- 1 generation backK201631 VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2020
- This deviceK232029 VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251505 VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector…Alafair Biosciences · 2025
- Descendant · cites it directly · 0 of its ownK251175 VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector…Alafair Biosciences · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041620 | Neura Wrap Nerve Protector | Integra Lifesciences Corp. | 2004 | 1 |
| −1 | K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020 | — |
| 0 (this device) | K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023 | — |
| +1 | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 K223640 Axoguard HA+ Nerve Protector (AGHA12)…score 12.3 · 5 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 |
|---|---|---|---|
| * | K201631 | VersaWrap Nerve ProtectorSummary page 5…Nerve Protector Common Name Cuff, Nerve Classification number 21 CFR 882.5275 Product Code JXI Predicate Device: VersaWrap Nerve Protector K201631 VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 2 companies; a new generation was cleared every 16.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K251505 (Alafair Biosciences, 2025) has gone furthest, with 0 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. 2023, 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/K232029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232029: VersaWrap 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/K232029
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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