ULTRABUTTON◊ Adjustable Fixation Device Indications
Download the Instructions for Use
The ULTRABUTTON Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The device facilitates repair / reconstruction through placement and retention of soft tissue within bone.
INDICATIONS FOR USE
The ULTRABUTTON Adjustable Fixation Device is indicated for soft tissue to bone fixation for: ACL/PCL repair / reconstruction, ACL/PCL patellar bone-tendonbone grafts, Double-Tunnel ACL reconstruction,Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, and Joint capsule closure.
CONTRAINDICATIONS• Surgical procedures other than those listed in the INDICATIONS FOR USE section.• Pathologic bone conditions, such as cystic changes or severe osteopenia, which would impair the secure fixation of the implant.• Insufficient quality or quantity of bone, inadequate bone stock or comminuted bone surfaces which could compromise secure fixation of the implant.• The use of this device may not be suitable for patients with insufficient or inadequate bone stock. The use of this device and the placement of implants must not bridge, disturb or disrupt the growth plate.• Physical conditions that would eliminate or tend to eliminate adequate implant support or retard healing, i.e., reduced blood supply, metabolic disorders that would impact bone density, or infections, etc.• Sensitivity to implant materials. Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation.• Conditions such as senility or mental illness which may preclude the patient’s ability or willingness to comply with physician instructions during the healing period