# K033230: Tracers TA Bone Cement Opacifier, Model TCR-TA

- Pathway: 510(k) (Special)
- Applicant: Parallax Medical, Inc.
- Decided: Dec 12, 2003 after 67 days
- Product code: MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- 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 K873689 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023445: Tracers Bone Cement Opacifier, Parallax Medical, Inc. (2003) Summary page 1.

## Indications for use
TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour TM Acrylic Resin to provide radiopacity for imaging purposes.

Source page: https://510kreport.com/device/K033230
Methodology: https://510kreport.com/methodology