510(k) · Cleared
ClearedParallax Acrylic Resin Cartridge with Tracers-TA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · NDN Cement, Bone, Vertebroplasty
Cleared on Jul 12, 2006 as substantially equivalent to K050864 (Arthrocare Corp., 2005) and 1 other predicate after a 145-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jul 12, 2006
- Review
- 145 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032945 (2004). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK032945 Simplex XStryker Corp. · 2004 · Recalled
- 2 generations backK042947 Parallax Acrylic Resin with Tracers, Model KP-Par-003Arthrocare Corp. · 2004
- 1 generation backK050864 Parallax Acrylic Resin with Tracers TAArthrocare Corp. · 2005
- This deviceK060425 Parallax Acrylic Resin Cartridge with Tracers-TAArthrocare Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032945 | Simplex X | Stryker Corp. | 2004 | 2 |
| −2 | K042947 | Parallax Acrylic Resin with Tracers, Model KP-Par-003 | Arthrocare Corp. | 2004 | — |
| −1 | K050864 | Parallax Acrylic Resin with Tracers TA | Arthrocare Corp. | 2005 | — |
| 0 (this device) | K060425 | Parallax Acrylic Resin Cartridge with Tracers-TA | Arthrocare Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 NDN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K050864 | Parallax Acrylic Resin with Tracers TASummary page 1…eric/Common Name: Bone Cement Predicate Device Parallax® Acrylic Resin with TRCERS®-Ta K050864 Parallax®Acrylic Resin Cartridge with TRACERS"~ K053180 Intended Use Parallax®D Acry… | 2005 |
| * | K053180 | Parallax Acrylic Resin Cartridge with TracersSummary page 1…Parallax® Acrylic Resin with TRCERS®-Ta K050864 Parallax®Acrylic Resin Cartridge with TRACERS"~ K053180 Intended Use Parallax®D Acrylic Resin Cartridge with TRACERS-Ta is intended for the fixation of pathological frac… | 2006 |
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 2 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Parallax® Acrylic Resin Cartridge with TRACERS-Ta is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060425 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060425: Parallax Acrylic Resin Cartridge with Tracers-TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060425
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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