# K070091: Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Apr 18, 2007 after 98 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: 3 generations back to K890925 (1989). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits, Stryker Corp. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K813338: Biopsy Needles & Trays, American Pharmaseal Div. Ahsc (1982). Our reading of the summary gave K813338, FDA’s number for Biopsy Needles & Trays (American Pharmaseal Div. Ahsc). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cardinal Health Jamshidi Coaxial Bone Biopsy Needle”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K171531: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (2017), 3 descendants of its own
- K172558: iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit (2017), 1 descendant of its own
- K242322: Bone Marrow Biopsy Needle (2025), 0 descendants of its own
- K192099: MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (2020), 0 descendants of its own
- K190177: J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, (2019), 0 descendants of its own

## Indications for use
This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.

Source page: https://510kreport.com/device/K070091
Methodology: https://510kreport.com/methodology