# K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Dec 17, 2003 after 86 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
Longest line of descent: 2 generations back to K890925 (1989). 4 ancestors in all.
29 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022169: Clearview Plus Bone and Vertebral Body Biopsy Needles, Parallax Medical, Inc. (2002) Summary page 1.
- K011206: Parallax Bone and Vertebral Body Biopsy and Infusion Needles, Parallax Medical, Inc. (2001)
- K990515: Mathis Vertebral and Bone Biopsy System, International Medical Systems (1999) Summary page 1.

## 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
- K070091: Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 (2007), 6 descendants of its own

## Indications for use
Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.

Source page: https://510kreport.com/device/K032943
Methodology: https://510kreport.com/methodology