# K063248: Arcuate Vertebral Augmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Mar 13, 2007 after 138 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: 5 generations back to K002652 (2001). 15 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040483: Equestra Fluid Delivery System, Medtronic Sofamor Danek, Inc. (2004) Summary page 1.
- K062452: Kit Mendec Spine and Delivery System, Tecres S.P.A. (2006) Summary page 1.
- K060148: Ebi Vertebroplasty Systems, Ebi, L.P. (2006) Summary page 1.
- K042691: Vertefix Vertebroplasty Procedure Set, Cook, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K072133: Avaflex Vertebral Augmentation Needle (2007), 3 descendants of its own

## Indications for use
The ARCUATE Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

Source page: https://510kreport.com/device/K063248
Methodology: https://510kreport.com/methodology