# K191709: V-STRUT Vertebral Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hyprevention Sas
- Decided: Mar 5, 2020 after 253 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: 11 generations back to K970097 (1997). 60 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132817: Kiva VCF Treatment System, Benvenue Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K240084: V-STRUT® Vertebral Implant (2024), 0 descendants of its own
- K221697: Injection Pin (Kip (02031-02061) (03031-03061)) (2023), 0 descendants of its own

## Indications for use
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.

Source page: https://510kreport.com/device/K191709
Methodology: https://510kreport.com/methodology