Alafair Biosciences · Class II · Cleared Jul 17, 2025
| K-number | K251175 |
| Device name | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) |
| Applicant | Alafair Biosciences |
| Product code | JXI |
| Device class | Class II |
| Decision date | Jul 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5275 |
VersaWrap Nerve Protector is a thin, flexible gelatinous implant designed to provide a protective interface between injured peripheral nerves and surrounding tissues during healing. It is indicated for management of peripheral nerve injuries where there has been no substantial loss of nerve tissue, and is designed to be non-constricting and absorbable after implantation.
The subject device shares the same materials of construction, chemical composition, material processing, and mechanism of action (providing a gliding surface and physical tissue separation) as the predicate device. The key difference is application method: the subject device is implanted as a gel, whereas the predicate device is implanted as a sheet form.
Not stated in this summary.
Substantial equivalence is claimed because the application method difference (gel vs. sheet) is not critical to intended use—both forms deliver the same therapeutic interface function with identical materials and mechanism of action. Animal studies in rats and bench testing (including gel integrity, handling, coverage, and migration assessments) demonstrated the gel formulation performs similarly to the predicate device without introducing new risks or affecting safety and effectiveness. The risk-based assessment identified no new or significantly modified existing risks.
View the full FDA submission: accessdata.fda.gov