# K023088: Bone Graft Syringe, Model 8600-00X0

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 2, 2002 after 15 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
No predicates in its family tree.
76 later devices descend from it; 5 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041991: Aspirex - Bone Marrow Aspirate Kit (2004), 73 descendants of its own
- 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

## Indications for use
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

Source page: https://510kreport.com/device/K023088
Methodology: https://510kreport.com/methodology