| K-number | K250346 |
| Device name | BonVie+ |
| Applicant | Elute, Inc. |
| Product code | MQV |
| Device class | Class II |
| Decision date | Feb 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3045 |
BonVie+ is an osteoconductive bone void filler implant designed to fill bony voids or gaps in the skeletal system (extremities and pelvis) caused by surgical creation or traumatic injury. The device resorbs over time and is replaced with bone during the healing process.
BonVie+ has identical chemical composition to its predicate device (hydroxyapatite, calcium carbonate, calcium chloride, and degradable polymers PCL, PEG, PLGA). The key difference is manufacturing: the predicate was supplied as preformed granules, while BonVie+ is provided as a powder and solution kit with a silicone mat that allows the user to fabricate granules of desired shapes and sizes intraoperatively.
ISO 10993 biocompatibility testing, sterilization and packaging validation, pyrogenicity testing/endotoxin monitoring, X-ray diffraction (XRD), compression testing, and usability testing.
Because BonVie+ has identical chemical composition and the same indications for use as the predicate device EP Granules BVF, and the available granule shapes and sizes are equivalent to the predicate, the manufacturing difference (powder/solution kit versus preformed granules) does not raise different questions of safety or effectiveness. The supporting biocompatibility and degradation data confirm the material properties are substantially equivalent.
View the full FDA submission: accessdata.fda.gov