# K070527: Arcuate Vertebral Augmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: May 4, 2007 after 70 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: 6 generations back to K002652 (2001). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063248: Arcuate Vertebral Augmentation System, Medtronic Sofamor Danek (2007). Cleared while this submission was under review Summary page 1.
- 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 1.
- K062424: Confidence EX High Viscosity Bone Cement, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 1.

## Most influential descendants
- K113452: Acu-Cut Vertebral Augmentation System (2012), 0 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/K070527
Methodology: https://510kreport.com/methodology