# K050864: Parallax Acrylic Resin with Tracers TA

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jun 17, 2005 after 73 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: 2 generations back to K032945 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042947: Parallax Acrylic Resin with Tracers, Model KP-Par-003, Arthrocare Corp. (2004) Summary page 1.

## Most influential descendants
- K060425: Parallax Acrylic Resin Cartridge with Tracers-TA (2006), 0 descendants of its own

## Indications for use
Parallax Acrylic Resin with TRACERS TA is indicated 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-cancer, myleoma).

Source page: https://510kreport.com/device/K050864
Methodology: https://510kreport.com/methodology