# K042947: Parallax Acrylic Resin with Tracers, Model KP-Par-003

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Dec 27, 2004 after 62 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: 1 generation back to K032945 (2004). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.

## Most influential descendants
- K053180: Parallax Acrylic Resin Cartridge with Tracers (2006), 1 descendant of its own
- K050864: Parallax Acrylic Resin with Tracers TA (2005), 1 descendant of its own
- K060425: Parallax Acrylic Resin Cartridge with Tracers-TA (2006), 0 descendants of its own

## Indications for use
Parallax® Acrylic Resin with TRACERS® 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 cancers, myleoma).

Source page: https://510kreport.com/device/K042947
Methodology: https://510kreport.com/methodology