Processed by MTF, designed and available through Synthes Spine, these allograft spacers are engineered to meet the specific demands of spinal applications.  Multiple heights accommodate individual patient anatomy, eliminating the time-consuming process of intraoperative graft creation.

Key Features & Benefits

• ACF Spacers are designed to meet the basic needs of ACF surgery;  they feature two sagittal profiles, lordotic or parallel, to restore anatomic alignment and a central cavity for osteobiologic material packing to create fusion through the implant   
• CorticoCancellous ACF Spacers feature a porous composition of dense cancellous bone that permits a rapid absorption of blood into the implant and are available in three sagittal profiles: lordotic, parallel or convex to restore anatomic alignment
• Advanced ACF Spacers feature a central cavity for osteobiologic material packing to create fusion through the implant; demineralized surfaces which exposes proteins inherent to bone growth necessary for fusion and incorporation of the implant with the vertebral bodies and are available in sagittal profiles, lordotic, parallel or convex to restore anatomic alignment

Indications

• Anterior Cervical Interbody Fusion

Notes:

• The FDA regulates donated human tissue under FDA regulation 21 CFR Part 1270, Human Tissue Intended for Transplantation and 21 CFR 1271, Human Cell, Tissue, and Cellular and Tissue-Based Product.  These regulations outline the requirements for donor screening, infectious disease testing, record keeping, and facility inspections.  Facilities, including MTF, that distribute human tissue intended for transplantation are not required to obtain FDA premarket approval (PMA), Investigational Device Exemption (IDE) or 510(k) clearance to distribute human tissues provided the tissue meets the FDA’s definition of human tissues as described in 21 CFR 1270 and 1271 

• Instruments are Class I devices