510(k) · Cleared
ClearedParallax Acrylic Resin 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 Jun 17, 2005 as substantially equivalent to K042947 (Arthrocare Corp., 2004) after a 73-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Jun 17, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032945 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK032945 Simplex XStryker Corp. · 2004 · Recalled
- 1 generation backK042947 Parallax Acrylic Resin with Tracers, Model KP-Par-003Arthrocare Corp. · 2004
- This deviceK050864 Parallax Acrylic Resin with Tracers TAArthrocare Corp. · 2005
- Descendant · cites it directly · 0 of its ownK060425 Parallax Acrylic Resin Cartridge with Tracers-TAArthrocare Corp. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060425Parallax Acrylic Resin Cartridge with Tracers-TAArthrocare Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032945 | Simplex X | Stryker Corp. | 2004 | 2 |
| −1 | K042947 | Parallax Acrylic Resin with Tracers, Model KP-Par-003 | Arthrocare Corp. | 2004 | — |
| 0 (this device) | K050864 | Parallax Acrylic Resin with Tracers TA | Arthrocare Corp. | 2005 | — |
| +1 | K060425 | Parallax Acrylic Resin Cartridge with Tracers-TA | Arthrocare Corp. | 2006 | — |
Descendants 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? (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 |
|---|---|---|---|
| * | K042947 | Parallax Acrylic Resin with Tracers, Model KP-Par-003Summary page 1…ion: Class II [Panel: Orthopedic Devices Predicate Devices Parallax" Acrylic Resin wkith TRAC[RS', K042947 Product Description Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone cement. Intended… | 2004 |
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 |
|---|---|---|---|
| K060425 | Parallax Acrylic Resin Cartridge with Tracers-TA | 2006 | 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 1 year and passes through 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K060425 (Arthrocare Corp., 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042947.
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 with TRACERS TA is indicated 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-cancer, myleoma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050864: Parallax Acrylic Resin with Tracers TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050864
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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