# K062365: Arthrex Aspirate Kit

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 29, 2006 after 46 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K003286 (2001). 7 ancestors in all.
37 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041991: Aspirex - Bone Marrow Aspirate Kit, Isotis Orthobiologics, Inc. (2004) Summary page 1.
- K022246: Modification to Symphony Graft Delivery System, Depuyacromed (2002) Summary page 1.
- K012738: Symphony Graft Delivery System (GDS), Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K121124: Arthrex Mixing and Delivery System (2012), 36 descendants of its own
- K133021: Mixing Syringe System (2014), 32 descendants of its own
- K141245: Etex Mixing and Delivery System (2014), 31 descendants of its own
- K161568: Bone Solutions Mixing and Delivery System (2016), 21 descendants of its own
- K170675: Graftgun Universal Graft Delivery System (2017), 11 descendants of its own

## Indications for use
The Arthrex Aspirate Kit is intended for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without pre-filling with a bone void filler (allograft, autograft or synthetic bone graft material). The kit is designed to facilitate the pre-mixing of autologous blood, bone marrow, I.V. fluids, platelet-rich plasma, or plasma with bone void filler and the delivery to an orthopedic surgical site, as deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K062365
Methodology: https://510kreport.com/methodology