# K043172: Trugraft BGS Syringe, Model 600-041

- Pathway: 510(k) (Traditional)
- Applicant: Osteobiologics, Inc.
- Decided: Jan 7, 2005 after 52 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 K994337 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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)
- K030208: Imbibe II Syringe, Orthovita, Inc. (2003) Summary page 1.
- K032130: Vitoss-Filled Cartridge, Orthovita, Inc. (2003) Summary page 1.

## Indications for use
TruGraftTM BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.

Source page: https://510kreport.com/device/K043172
Methodology: https://510kreport.com/methodology