# K052638: Abbott Spine, Inc. Spinnaker System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Spine, Inc.
- Decided: Nov 7, 2005 after 42 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.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Capture Vertebral Body and Bone Biopsy Kit: named in the summary without a submission number
- (no number) Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit: named in the summary without a submission number

## Most influential descendants
- 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
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own

## Indications for use
The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Source page: https://510kreport.com/device/K052638
Methodology: https://510kreport.com/methodology