# K130703: Vivorte BVF

- Pathway: 510(k) (Traditional)
- Applicant: Vivorte, Inc.
- Decided: Sep 12, 2013 after 181 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960978 (1996). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090855: Equivabone Osteoinductive Bone Graft Substitute, Etex Corp. (2009) Summary page 1.
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Most influential descendants
- K143547: Vivorte Trabexus EB (2015), 0 descendants of its own

## Recalls of this device
- Sep 9, 2018 · Class II · Z-2024-2021: incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018

## Indications for use
Vivortt BVFTh is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bane matrix (DBM). Vivartd BVFr' 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. Vivortd BVF"~' may be manually applied to the bony defect or applied to the defect through a cannula. Vivortd BVFr' is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Source page: https://510kreport.com/device/K130703
Methodology: https://510kreport.com/methodology