# K171531: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Sep 11, 2017 after 109 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890925 (1989). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813338: Biopsy Needles & Trays, American Pharmaseal Div. Ahsc (1982) Summary page 4.
- K913306: Bone-Temno/Sternum-Temno, Proact, Ltd. (1991) Summary page 4.
- K003370: Jamshidi Marrow Acquisition Cradle, Allegiance Healthcare Corp. (2000) Summary page 4.
- K070091: Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208, Cardinal Health, Inc. (2007) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Aug 24, 2021 · Class II · Z-0154-2022: Due to misbranded products shipped to customers.
- Aug 24, 2021 · Class II · Z-0153-2022: Due to misbranded products shipped to customers.
- Jun 23, 2021 · Class II · Z-2247-2021: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- Jun 23, 2021 · Class II · Z-2248-2021: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- Mar 17, 2020 · Class II · Z-1689-2020: Sterility compromised due to packaging pouches that may not be sealed properly
- Aug 1, 2019 · Class II · Z-2411-2019: Product Pouches may not be sealed properly and compromise the sterility of the device

## Indications for use
Jamshidi Bone Marrow Biopsy/Aspiration Needle — DJ: Intended use for the posterior iliac crest biopsy technique. Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle - TJ: Intended use for the posterior iliac crest biopsy technique. Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle - EJ: Indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

Source page: https://510kreport.com/device/K171531
Methodology: https://510kreport.com/methodology