# K051720: Synthes (Usa) Bone Marrow Aspiration Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 25, 2005 after 28 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (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 its predicate without a number.
- (no number) Merit Medical Systems, Disposable Coronary Control Syringe: named in the summary without a submission number
- (no number) Wright Medical Technologies, Bone Graft Syringe: named in the summary without a submission number

## Recalls of this device
- Jan 26, 2011 · Not classified · Z-3273-2011: Firm became aware that some systems were released to stock without going through the sterilization process.

## Indications for use
The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids.

Source page: https://510kreport.com/device/K051720
Methodology: https://510kreport.com/methodology