# K041976: Smith & Nephew Graft Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 23, 2004 after 32 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 5, 2008 · Not classified · Z-2446-2008: Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.
- Aug 5, 2008 · Not classified · Z-2447-2008: Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.

## Indications for use
The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site, In addition, it is designed to facilitate pre-mixing of bone graft materials with IV. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements

Source page: https://510kreport.com/device/K041976
Methodology: https://510kreport.com/methodology