# K071937: Bonalive Granules and Bonalive Plates

- Pathway: 510(k) (Traditional)
- Applicant: Vivoxid, Ltd.
- Decided: Oct 19, 2007 after 98 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022665: Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe, Hohenstein Enterprises, Inc. (2002) Summary page 1.
- K053387: Perioglas Bone Graft Particulate, Novabone Products, LLC (2006) Summary page 1.

## Indications for use
BonAliveTM Granules and BonAliveTM Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.

Source page: https://510kreport.com/device/K071937
Methodology: https://510kreport.com/methodology