# K030208: Imbibe II Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Apr 16, 2003 after 85 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.
121 later devices descend from it; 7 cite it directly.
0 of 122 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 its predicate without a number.
- (no number) Piston Syringe: named in the summary without a submission 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
- K032130: Vitoss-Filled Cartridge (2003), 50 descendants of its own
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), 47 descendants of its own
- K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System (2007), 47 descendants of its own

## Indications for use
The IMBIBE I1 Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon’s choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Source page: https://510kreport.com/device/K030208
Methodology: https://510kreport.com/methodology