# K071199: Bonalive Granules

- Pathway: 510(k) (Traditional)
- Applicant: Vivoxid, Ltd.
- Decided: Feb 1, 2008 after 277 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: 3 generations back to K960978 (1996). 4 ancestors in all.
8 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)
- K021336: Novabone-Resorbable Bone Graft Substitute, Novabone Products, LLC (2002) Summary page 1.

## Most influential descendants
- K191274: BonAlive Granules (2019), 7 descendants of its own
- 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

## 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 provides 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. The device is not intended for use in posterolateral spine applications. BonAlive® granules is not indicated for use in load-bearing applications, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Source page: https://510kreport.com/device/K071199
Methodology: https://510kreport.com/methodology