# K041344: Open Bore Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Isotis NV
- Decided: Jul 16, 2004 after 57 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 K841201 (1984). 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)
- K972842: Interpore Inducer Bone Graft Delivery Syringe, Interpore Intl. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K011087: Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe, Orthovita, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K041344
Methodology: https://510kreport.com/methodology