Division: United States
The BIOINTRAFIX® ACL Fixation System is designed to provide soft tissue tibial fixation for ACL reconstruction. BIOINTRAFIX System, with its unique patented sheath and screw implant design offers a novel technique to achieve secure tibial fixation. BIOINTRAFIX System is made from BIOCRYL® Material, a bio-absorbable material that contains osteoconductive TCP.
The BIOINTRAFIX System Tibial Tapered Screws and Sheaths are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
|ß-TCP Bioabsorbable Material||The BIO-INTRAFIX Screw and Sheath are molded from a composite of PLA and osteoconductive TCP (Tricalcium Phosphate).1 TCP provides the osteoconductive bioceramic material necessary to promote bone growth into the sheath and screw. ß-TCP has been shown to dissolve and reabsorb more quickly than HAp (Hydroxyapatite). Invivo studies show that ß-TCP forms a strong bone-implant interface, bonding to bone and exhibiting osteoconductive characteristics.1|
|Enhanced bone-to-graft contact||
The patented screw and sheath design enhances bone-to-graft contact and strength through:
|Strength of fixation||Tested in human cadaver bone, the BIO-INTRAFIX System demonstrated excellent fixation, with >1000N pull-out strength1, and allows rigid absorbable material to perform like a flexible plastic sheath. Tested in an independent study (against five other tibial soft tissue fixation systems), INTRAFIX® Fixation System demonstrated the highest strength and stiffness with the lowest graft displacement.2|
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.