# K100754: Graft Delivery System Model SA-6115

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Jun 9, 2010 after 84 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: 4 generations back to K013966 (2002). 15 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System, Biomet, Inc. (2007) Summary page 1.
- K043261: Harvest Graft Delivery Syringe, Harvest Technologies, Corp. (2005) Summary page 1.

## Most influential descendants
- K111632: Infill Graft Delivery System (2011), 41 descendants of its own
- K121476: Infill Graft Delivery System (2012), 40 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
FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K100754
Methodology: https://510kreport.com/methodology