# K991893: Parallax Tracer Radiopaque Particles

- Pathway: 510(k) (Traditional)
- Applicant: Parallax Medical, Inc.
- Decided: Aug 13, 1999 after 71 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: 1 generation back to K873689 (1987). 1 ancestor in all.
2 later devices descend 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)
- K873689: Cranioplastic, Acrylic Cranioplasty Material, Dentsply Intl. (1987). Our OCR of the scanned summary read K873698, FDA’s number for Sterilized Dental Bit Packaging (Florida Diamond Instruments Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Codman Cranioplastic™, Acrylic Cranioplasty Material”.

## Most influential descendants
- K023445: Tracers Bone Cement Opacifier (2003), 1 descendant of its own
- K033230: Tracers TA Bone Cement Opacifier, Model TCR-TA (2003), 0 descendants of its own

## Indications for use
Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 — Slow Set) to provide radiopacity for imaging purposes.

Source page: https://510kreport.com/device/K991893
Methodology: https://510kreport.com/methodology