# K011087: Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Sep 19, 2001 after 162 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.
40 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023074: Imbibe Bone Marrow Aspiration Syringe (2003), 38 descendants of its own
- 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

Source page: https://510kreport.com/device/K011087
Methodology: https://510kreport.com/methodology