# K180853: EP Granules™ BVF

- Pathway: 510(k) (Traditional)
- Applicant: Elute, Inc.
- Decided: Aug 6, 2018 after 126 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: 6 generations back to K960978 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 4.
- K082073: Actifuse Flow Bone Graft Substitute, Apatech, Ltd. (2008) Summary page 4.

## Most influential descendants
- K250346: BonVie+ (2025), 0 descendants of its own

## Indications for use
EP Granules™ BVF 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. EP Granules™ BVF resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K180853
Methodology: https://510kreport.com/methodology