# K250346: BonVie+

- Pathway: 510(k) (Special)
- Applicant: Elute, Inc.
- Decided: Feb 26, 2025 after 20 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960978 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180853: EP Granules™ BVF, Elute, Inc. (2018) Summary page 6.

## Indications for use
BonVie+ is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. BonVie+ resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K250346
Methodology: https://510kreport.com/methodology