# K110183: Arthrocare Parallax Contour Vertebral Augmentation Device

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Feb 16, 2011 after 26 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: 8 generations back to K002652 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100479: Parallax Contour Vertebral Augmentation Device, Arthrocare Corp. (2010) Summary page 1.

## Indications for use
The ArthroCare® Parallax® Contour® Vertebral Augmentation Device - enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma,

Source page: https://510kreport.com/device/K110183
Methodology: https://510kreport.com/methodology