# K060148: Ebi Vertebroplasty Systems

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Mar 13, 2006 after 53 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: 3 generations back to K890925 (1989). 7 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits, Stryker Corp. (2003) Summary page 1.
- K052638: Abbott Spine, Inc. Spinnaker System, Abbott Spine, Inc. (2005) Summary page 1.
- K040483: Equestra Fluid Delivery System, Medtronic Sofamor Danek, Inc. (2004) Summary page 1.

## Most influential descendants
- K063248: Arcuate Vertebral Augmentation System (2007), 17 descendants of its own
- K070293: Benvenue VCF Osteo Coil System (2007), 10 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own
- K202393: SpineJack Expansion Kit (2020), 3 descendants of its own

## Indications for use
The EBI Vertebroplasty Systems are indicated to deliver bone cement legally cleared for use in the spine for the treatment of compression fractures of a vertebral body.

Source page: https://510kreport.com/device/K060148
Methodology: https://510kreport.com/methodology