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About this product

Division: Mitek Sports Medicine
Category: ACL Reconstruction

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. 

BIOINTRAFIX ACL Fixation System Implant BIOINTRAFIX ACL Fixation System Inside Right Knee

Indications for Use

The BIOINTRAFIX System Tibial Tapered Screws and Sheaths are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Features & Benefits

Features Benefits
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:
  • Concentric screw placement
  • 360° graft placement
  • Improved engagement 
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.
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