# K143547: Vivorte Trabexus EB

- Pathway: 510(k) (Special)
- Applicant: Vivorte, Inc.
- Decided: Jan 14, 2015 after 30 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: 9 generations back to K960978 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130703: Vivorte BVF, Vivorte, Inc. (2013) Summary page 4.

## 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
Vivorté Trabexus™ EB™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté Trabexus™ EB™ 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. Vivorté Trabexus™ EB™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus™ EB™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Source page: https://510kreport.com/device/K143547
Methodology: https://510kreport.com/methodology