# K132817: Kiva VCF Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Benvenue Medical, Inc.
- Decided: Jan 24, 2014 after 137 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K970097 (1997). 59 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063606: Modification to Staxx FX System, Spine Wave, Inc. (2007) Summary page 2.
- K070293: Benvenue VCF Osteo Coil System, Benvenue Medical, Inc. (2007) Summary page 2.
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 2.
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A, Kyphon, Inc. (2001) Summary page 2.

## Most influential descendants
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own
- K202393: SpineJack Expansion Kit (2020), 3 descendants of its own
- K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (2021), 2 descendants of its own
- K191709: V-STRUT Vertebral Implant (2020), 2 descendants of its own
- K223294: SpineJack® Expansion Kit (2022), 1 descendant of its own

## Indications for use
The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

Source page: https://510kreport.com/device/K132817
Methodology: https://510kreport.com/methodology