# K191274: BonAlive Granules

- Pathway: 510(k) (Traditional)
- Applicant: Bonalive Biomaterials, Ltd.
- Decided: Aug 7, 2019 after 86 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: 4 generations back to K960978 (1996). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071199: Bonalive Granules, Vivoxid, Ltd. (2008) Summary page 5.

## Most influential descendants
- K231528: Bonalive Orthopedics granules (2023), 6 descendants of its own
- K234013: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg  OSTEOCRETE™ (2024), 3 descendants of its own
- K242372: Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (2024), 2 descendants of its own
- K251522: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (2025), 1 descendant of its own
- K262230: Mg OSTEOREVIVE™;Mg OSTEOCRETE™ (2026), 0 descendants of its own

## Indications for use
BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.

Source page: https://510kreport.com/device/K191274
Methodology: https://510kreport.com/methodology