# K231528: Bonalive Orthopedics granules

- Pathway: 510(k) (Traditional)
- Applicant: Bonalive Biomaterials, Ltd.
- Decided: Jul 11, 2023 after 46 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: 5 generations back to K960978 (1996). 6 ancestors in all.
6 later devices descend from it; 4 cite 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)
- K191274: BonAlive Granules, Bonalive Biomaterials, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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
- K242782: GlassBone Granules (2024), 0 descendants of its own

## Indications for use
Bonalive® Orthopedics granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K231528
Methodology: https://510kreport.com/methodology