510(k) · Cleared

Cleared

Tracers TA Bone Cement Opacifier, Model TCR-TA

K033230510(k) SpecialCleared Dec 12, 200367-day reviewClass II21 CFR 882.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Parallax Medical, Inc. · MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Cleared on Dec 12, 2003 as substantially equivalent to K023445 (Parallax Medical, Inc., 2003) after a 67-day review. Its family tree reaches back 3 generations to 1987.

Decided: Dec 12, 2003
Review: 67 days
Class: Class II
Product code: MYU
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K873689 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
2 generations backK991893 Parallax Tracer Radiopaque ParticlesParallax Medical, Inc. · 1999
1 generation backK023445 Tracers Bone Cement OpacifierParallax Medical, Inc. · 2003
This deviceK033230 Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K873689	Cranioplastic, Acrylic Cranioplasty Material	Dentsply Intl.	1987	—
−2	K991893	Parallax Tracer Radiopaque Particles	Parallax Medical, Inc.	1999	—
−1	K023445	Tracers Bone Cement Opacifier	Parallax Medical, Inc.	2003	—
0 (this device)	K033230	Tracers TA Bone Cement Opacifier, Model TCR-TA	Parallax Medical, Inc.	2003	—

FIG. 1 — Lineage of K033230, 1987–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MYU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K023445	Tracers Bone Cement Opacifier Summary page 1 …MYU D. Predicate Device Identification The subject device is substantially equivalent to TRACERS® Bone Cement Opacifier (K023445). E. Intended Use TRACERS® Ta Bone Cement Op acifier is intended for use as an additive to…	Parallax Medical, Inc.	2003	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All MYU devices

MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MYU

FDA has decided no MYU device since 2007.

Median 510(k) review, days · MYU

Too few MYU 510(k)s in any year since 2007 to give a median.

Recalls per year · MYU

No recall names MYU since 2007.

Adverse event reports per year · MYU

No MAUDE report names MYU since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033230 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033230: Tracers TA Bone Cement Opacifier, Model TCR-TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033230

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026