510(k) · Cleared
ClearedTracers Bone Cement Opacifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parallax Medical, Inc. · MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Cleared on Mar 11, 2003 as substantially equivalent to K991893 (Parallax Medical, Inc., 1999) after a 147-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Mar 11, 2003
- Review
- 147 days
- Class
- Class II
- Product code
- MYU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873689 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 1 generation backK991893 Parallax Tracer Radiopaque ParticlesParallax Medical, Inc. · 1999
- This deviceK023445 Tracers Bone Cement OpacifierParallax Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK033230 Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033230Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −1 | K991893 | Parallax Tracer Radiopaque Particles | Parallax Medical, Inc. | 1999 | — |
| 0 (this device) | K023445 | Tracers Bone Cement Opacifier | Parallax Medical, Inc. | 2003 | — |
| +1 | K033230 | Tracers TA Bone Cement Opacifier, Model TCR-TA | Parallax Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K991893 | Parallax Tracer Radiopaque ParticlesSummary page 1…MYU D. Predicate De vice Iden tifica tion The subject device is substantially equivalent to TRACERS Bone Cement Opacifier (K991893). E. Intended Use TRACERS Bone Cement Opacifier is intended for use as an additive to Secour… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033230 | Tracers TA Bone Cement Opacifier, Model TCR-TA | 2003 | 0 |
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 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033230 (Parallax Medical, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MYU devicesMYU 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023445: Tracers Bone Cement Opacifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023445
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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