# K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 6, 2007 after 108 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 K003286 (2001). 7 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030208: Imbibe II Syringe, Orthovita, Inc. (2003) Summary page 1.
- K022246: Modification to Symphony Graft Delivery System, Depuyacromed (2002) Summary page 1.
- K021071: PCCS Graft Delivery System, Biomet, Inc. (2002) Summary page 1.

## Most influential descendants
- K100754: Graft Delivery System Model SA-6115 (2010), 45 descendants of its own
- 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

## Indications for use
CDO TM System The CDO TM System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements. Graft Preparation System The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with 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/K072330
Methodology: https://510kreport.com/methodology