# K011206: Parallax Bone and Vertebral Body Biopsy and Infusion Needles

- Pathway: 510(k) (Abbreviated)
- Applicant: Parallax Medical, Inc.
- Decided: Jul 18, 2001 after 90 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022169: Clearview Plus Bone and Vertebral Body Biopsy Needles (2002), 34 descendants of its own
- K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits (2003), 29 descendants of its own
- K060148: Ebi Vertebroplasty Systems (2006), 18 descendants of its own
- K063248: Arcuate Vertebral Augmentation System (2007), 17 descendants of its own
- K070293: Benvenue VCF Osteo Coil System (2007), 10 descendants of its own

Source page: https://510kreport.com/device/K011206
Methodology: https://510kreport.com/methodology