510(k) · Cleared
ClearedParallax Acrylic Resin with Tracers, Model KP-Par-003
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 Dec 27, 2004 as substantially equivalent to K032945 (Stryker Corp., 2004) after a 62-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it.
- Decided
- Dec 27, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032945 (2004). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032945 Simplex XStryker Corp. · 2004 · Recalled
- This deviceK042947 Parallax Acrylic Resin with Tracers, Model KP-Par-003Arthrocare Corp. · 2004
- Descendant · cites it directly · 1 of its ownK053180 Parallax Acrylic Resin Cartridge with TracersArthrocare Corp. · 2006
- Descendant · cites it directly · 1 of its ownK050864 Parallax Acrylic Resin with Tracers TAArthrocare Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK060425 Parallax Acrylic Resin Cartridge with Tracers-TAArthrocare Corp. · 2006
Most influential descendants
Showing 3 of 3 · See all- K053180Parallax Acrylic Resin Cartridge with TracersArthrocare Corp. · 2006 · cites it directly1descendant
- K050864Parallax Acrylic Resin with Tracers TAArthrocare Corp. · 2005 · cites it directly1descendant
- K060425Parallax Acrylic Resin Cartridge with Tracers-TAArthrocare Corp. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032945 | Simplex X | Stryker Corp. | 2004 | 2 |
| 0 (this device) | K042947 | Parallax Acrylic Resin with Tracers, Model KP-Par-003 | Arthrocare Corp. | 2004 | — |
| +1 | K053180 | Parallax Acrylic Resin Cartridge with Tracers | Arthrocare Corp. | 2006 | — |
| +1 | K050864 | Parallax Acrylic Resin with Tracers TA | Arthrocare Corp. | 2005 | — |
| +2 | K060425 | Parallax Acrylic Resin Cartridge with Tracers-TA | Arthrocare Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K032945 | Simplex XSummary page 1…Parallax® Acrylic Resin with TRACERS® Generic/Common Name: Bone Cement Predicate Device SpineplexTM Radiopaque Bone Cement K032945 Intended Use Parallax® Acrylic Resin with TRACERS' is indicated for the fixation of pathological fractures of the vertebral body… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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® 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 cancers, myleoma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042947: Parallax Acrylic Resin with Tracers, Model KP-Par-003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042947
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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