# K100479: Parallax Contour Vertebral Augmentation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Sep 21, 2010 after 215 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). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072133: Avaflex Vertebral Augmentation Needle, Cardinal Health, Inc. (2007) Summary page 1.
- (no number) Parallax Contour Osteotome: named in the summary without a submission number
- (no number) Access Needle Kits: named in the summary without a submission number

## Most influential descendants
- K110183: Arthrocare Parallax Contour Vertebral Augmentation Device (2011), 0 descendants of its own

## Indications for use
The ArthroCare® Parallax® Contour® Vertebral Augmentation Device 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/K100479
Methodology: https://510kreport.com/methodology