# K113452: Acu-Cut Vertebral Augmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Ascendx Spine, Inc.
- Decided: Feb 17, 2012 after 88 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: 7 generations back to K002652 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070527: Arcuate Vertebral Augmentation System, Medtronic Sofamor Danek (2007) Summary page 1.

## Indications for use
The Acu-Cut 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. It is intended to be used in combination with Ascendx Cement.

Source page: https://510kreport.com/device/K113452
Methodology: https://510kreport.com/methodology