# K060425: Parallax Acrylic Resin Cartridge with Tracers-TA

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jul 12, 2006 after 145 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: 3 generations back to K032945 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050864: Parallax Acrylic Resin with Tracers TA, Arthrocare Corp. (2005) Summary page 1.
- K053180: Parallax Acrylic Resin Cartridge with Tracers, Arthrocare Corp. (2006) Summary page 1.

## Indications for use
Parallax® Acrylic Resin Cartridge with TRACERS-Ta is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K060425
Methodology: https://510kreport.com/methodology