# K041991: Aspirex - Bone Marrow Aspirate Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Sep 16, 2004 after 55 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: 1 generation back to K023088 (2002). 2 ancestors in all.
73 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030208: Imbibe II Syringe, Orthovita, Inc. (2003) Summary page 1.
- K023088: Bone Graft Syringe, Model 8600-00X0, Wrightmedicaltechnologyinc (2002) Summary page 1.

## Most influential descendants
- K043261: Harvest Graft Delivery Syringe (2005), 51 descendants of its own
- K100754: Graft Delivery System Model SA-6115 (2010), 45 descendants of its own
- K111632: Infill Graft Delivery System (2011), 41 descendants of its own
- K121476: Infill Graft Delivery System (2012), 40 descendants of its own
- K062986: Medtronic Graft Delivery Syringe (2006), 37 descendants of its own

## Indications for use
Aspirex TM - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone void filler and deliver to the orthopedic surgical site.

Source page: https://510kreport.com/device/K041991
Methodology: https://510kreport.com/methodology