# K023445: Tracers Bone Cement Opacifier

- Pathway: 510(k) (Special)
- Applicant: Parallax Medical, Inc.
- Decided: Mar 11, 2003 after 147 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: 2 generations back to K873689 (1987). 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)
- K991893: Parallax Tracer Radiopaque Particles, Parallax Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- K033230: Tracers TA Bone Cement Opacifier, Model TCR-TA (2003), 0 descendants of its own

## Indications for use
TRACERSO Bone Cement Opacifier is intended for use as an additive to SecourTMAcrylic Resin or Codman CranioplasticTM(Type I - Slow Set) to provide radiopacity for imaging purposes.

Source page: https://510kreport.com/device/K023445
Methodology: https://510kreport.com/methodology