# K060095: Modification to: Vaclok Syringe

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 10, 2006 after 28 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 K994253 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023088: Bone Graft Syringe, Model 8600-00X0, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K994253: Vaclok Syringe, Merit Medical Systems, Inc. (2000) Summary page 1.

## Indications for use
The VACLOK TM Syringe Kit is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids, The VACLOK TM Syringe Kit 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/K060095
Methodology: https://510kreport.com/methodology