Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5275](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5275) → JXI — Cuff, Nerve # JXI · Cuff, Nerve _Neurology · 21 CFR 882.5275 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI ## Overview - **Product Code:** JXI - **Device Name:** Cuff, Nerve - **Regulation:** [21 CFR 882.5275](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5275) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **Implant:** yes ## Identification A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 40) Showing 20 most recent of 40 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260245](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K260245.md) | SILKBridge | KLISBio S.r.l. | Apr 9, 2026 | SESE | | [K253363](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K253363.md) | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | Jan 17, 2026 | SESE | | [K251505](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K251505.md) | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | Jul 22, 2025 | SESE | | [K251175](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K251175.md) | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | Jul 17, 2025 | SESE | | [K243889](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K243889.md) | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell, Ltd. | Apr 2, 2025 | SESE | | [K242113](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K242113.md) | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | Apr 2, 2025 | SESE | | [K233322](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K233322.md) | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | Jun 21, 2024 | SESE | | [K233533](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K233533.md) | NerveTape | Biocircuit Technologies, Inc. | Feb 12, 2024 | SESE | | [K230794](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K230794.md) | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | Jan 29, 2024 | SESE | | [K232029](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K232029.md) | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | Nov 2, 2023 | SESE | | [K231708](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K231708.md) | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | Oct 12, 2023 | SESE | | [K223640](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K223640.md) | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | Apr 7, 2023 | SESE | | [K210665](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K210665.md) | Nerve Tape | Biocircuit Technologies, Incorporated | Jul 15, 2022 | SESE | | [K202234](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K202234.md) | NervAlign Nerve Cuff | Renerve, Ltd. | Feb 10, 2022 | SESE | | [K201631](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K201631.md) | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | Sep 14, 2020 | SESE | | [K190246](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K190246.md) | NeuroShield | Monarch Bioimplants GmbH | May 31, 2019 | SESE | | [K180222](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K180222.md) | Reaxon Plus | Medovent GmbH | Apr 24, 2018 | SESE | | [K163446](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K163446.md) | AxoGen Nerve Cap | Axogen Corporation | Aug 8, 2017 | SESE | | [K170656](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K170656.md) | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | Jun 1, 2017 | SESE | | [K163457](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K163457.md) | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | Jan 6, 2017 | SESE | ## Top Applicants - Collagen Matrix, Inc. — 4 clearances - Axogen Corporation — 3 clearances - Polyganics B.V., — 3 clearances - Alafair Biosciences — 2 clearances - Alafair Biosciences, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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