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The Matryx™ Interference Screw is intended for use in interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The Matryx™ Interference Screw is not intended for use in and is contraindicated for 1) Insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitations and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate device previously cleared Matryx Interference Screw is made of the very same raw material. Lengths of implant are 25 38 mm . Diameters of implant are 9 mm-11mm. . The only modifications that were made are: Amendment of a new screw sizes. - Thread profile for longer 9 mm screw is similar with already cleared Matryx™ ... Interference Screws (K052080). The thread profile of diameter 10 mm and 11 mm screws is similar with predicate device ConMed Linvatec BioScrew (K933719, K952831, K973758) Amendment of Bone Taps for screws of 9 mm x 38 mm, 10 mm and 11 mm. - Reference numbers for these new screw versions. These changes are updated in . labelling. Revision of insert sheet covering the new screw sizes. -