# K131133: Vivorte BVF Lite

- Pathway: 510(k) (Traditional)
- Applicant: Vivorte, Inc.
- Decided: Aug 12, 2013 after 111 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: 1 generation back to K011897 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Most influential descendants
- K143549: Vivorte Trabexus (2015), 0 descendants of its own

## Indications for use
Vivort6 BVFTM LiteTM is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivort6 BVFTM LiteTM is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivort6 BVFTM LiteTM may be manually applied to the bony defect or applied to the defect through a cannula. Vivort6 BVFTM LiteTM is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Source page: https://510kreport.com/device/K131133
Methodology: https://510kreport.com/methodology