# K023074: Imbibe Bone Marrow Aspiration Syringe

- Pathway: 510(k) (Special)
- Applicant: Orthovita, Inc.
- Decided: Mar 11, 2003 after 176 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 K011087 (2001). 1 ancestor in all.
38 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011087: Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe, Orthovita, Inc. (2001)

## Most influential descendants
- K062986: Medtronic Graft Delivery Syringe (2006), 37 descendants of its own
- K121124: Arthrex Mixing and Delivery System (2012), 36 descendants of its own
- K133021: Mixing Syringe System (2014), 32 descendants of its own
- K141245: Etex Mixing and Delivery System (2014), 31 descendants of its own
- K161568: Bone Solutions Mixing and Delivery System (2016), 21 descendants of its own

## Indications for use
The Imbibe Bone Marrow Aspiration 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 autologous blood or bone marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Source page: https://510kreport.com/device/K023074
Methodology: https://510kreport.com/methodology