510(k) · Cleared
ClearedParallax Ezflow Cement Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · OAR Injector, Vertebroplasty (Does Not Contain Cement)
Cleared on Sep 6, 2005 after a 63-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Sep 6, 2005
- Review
- 63 days
- Class
- Class I
- Product code
- OAR
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 1 citing it directly.
- This deviceK051820 Parallax Ezflow Cement Delivery SystemArthrocare Corp. · 2005
- Descendant · cites it directly · 4 of its ownK081713 Vertebral Access System by VidacareVidacare Corporation · 2008
- Descendant · 2 generations on · 3 of its ownK112468 The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK113872 The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012 · Recalled
- Descendant · 4 generations on · 0 of its ownK230015 OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone…Laurane Medical Sas · 2023
- Descendant · 4 generations on · 0 of its ownK213896 BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022
Most influential descendants
Showing 5 of 5 · See all- K081713Vertebral Access System by VidacareVidacare Corporation · 2008 · cites it directly4descendants
- K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011 · 2 generations on3descendants
- K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012 · 3 generations on2descendants
- K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas · 2023 · 4 generations on0descendants
- K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051820 | Parallax Ezflow Cement Delivery System | Arthrocare Corp. | 2005 | — |
| +1 | K081713 | Vertebral Access System by Vidacare | Vidacare Corporation | 2008 | — |
| +2 | K112468 | The Oncontrol Bone Access System by Vidacare | Regulatory Specialists, Inc. | 2011 | — |
| +3 | K113872 | The Oncontrol Bone Access and Bone Biopsy System by Vidacare | Vidacare Corporation | 2012 | 2 |
| +4 | K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit… | Laurane Medical Sas | 2023 | — |
| +4 | K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 OAR? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K980064 | Parallax® Cement Injector Kit Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…0 Trade Name: Parallax® EZFlow™ Cement Delivery System Device Code: OAR and KIH Generic/Common Name: Cement Dispenser Predicate Devices Parallax® Cement Injector Kit K980064 Intended Use Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax… |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081713 | Vertebral Access System by Vidacare | 2008 | 4 |
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?
- Of its descendants, K081713 (Vidacare Corporation, 2008) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OAR devicesOAR Injector, Vertebroplasty (Does Not Contain Cement): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OAR
FDA has decided no OAR device since 2007.
Median 510(k) review, days · OAR
Too few OAR 510(k)s in any year since 2007 to give a median.
Recalls per year · OAR
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAR
12in 2025
MAUDE reports naming product code OAR, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 6 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 1 | 22 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 1 | 17 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051820: Parallax Ezflow Cement Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051820
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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