# K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

- Pathway: 510(k) (Traditional)
- Applicant: Medax Srl Unipersonale
- Decided: Nov 13, 2017 after 103 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 K960064 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142125: New Medax Biopsy Systems, Medax Srl Unipersonale (2015) Summary page 4.
- K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument, Bard Peripheral Vascular, Inc. (2014) Summary page 4.
- K092338: Medax Unipersonale SRL, Medax Unipersonale Srl (2011) Summary page 4.
- K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles, Biopsybell S.R.L. (2014) Summary page 4.

## Most influential descendants
- 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

## Indications for use
MEDONE Soft tissue automatic disposable biopsy system: MEDONE biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy. MEDCUT automatic disposable biopsy system: MEDCUT biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy. MEDEM Mallarmé bone marrow aspiration needle: MEDEM biopsy needle must be used for bone marrow aspiration from sternum or iliac crest. MEDBONE Bone marrow biopsy system: MEDBONE biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy. MEDLOCK Bone marrow biopsy and aspiration system: MEDLOCK biopsy system must be used for bone marrow aspiration and the posterior iliac crest biopsy.

Source page: https://510kreport.com/device/K172344
Methodology: https://510kreport.com/methodology