# K051820: Parallax Ezflow Cement Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Sep 6, 2005 after 63 days
- Product code: OAR (Injector, Vertebroplasty (Does Not Contain Cement))
- Device class: 1
- Regulation: 21 CFR 888.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Most influential descendants
- K081713: Vertebral Access System by Vidacare (2008), 4 descendants of its own
- K112468: The Oncontrol Bone Access System by Vidacare (2011), 3 descendants of its own
- K113872: The Oncontrol Bone Access and Bone Biopsy System by Vidacare (2012), 2 descendants of its own
- K230015: OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (2023), 0 descendants of its own
- K213896: BD Trek Powered Bone Biopsy System (2022), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K051820
Methodology: https://510kreport.com/methodology