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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 limitation 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 Osteo ACL Screw is made of the very same raw material. Lengths of implant are 20 30 mm - Diameters of implant are 7mm-9mm. - The only modifications that were made are: - Change of trade name. This change is updated in labelling. - Minor modifications and further definition of tolerances of screw design.

SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization. SmartPin® is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical Dearing 'oches, 'osteochonies and cancellous/non-load bearing fragments. SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and Sthart mis is not intended for assess cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) treatment of which patient co operation callier see effect of SmartPin® upon the healing of growth plate has not been tested clinically.

The device description of SmartPin® is as follows: - Composed of poly-96L/4D-lactide copolymer - - Tapered, smooth pins - - Lengths 10 70mm - - Diameters 1.1, 1.5, 2.0, 3.2 and 4.5 mm - The dimensions and shape are completely identical with Linvatec Biomaterials The unnersholis and brin) (K010983), SmartPin® PDX (the previous PLGA Pin) (K003659) and Biofix SR-PGA Pin (K890902).

The Osteo ACL 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 Osteo ACL 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 limitation 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 separas 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 devices like Mitek Biocryl Interference Screws (013572) and Biocomposites Ltd Biolok (K993630, K002070) are utilizing mixture of poly-L-lactide and tri-calsium phosphate. Lengths of implant are 20 30 mm -Diameters of implant are 7mm-11mm. The only modifications that were made are: Amendment of a new raw material option, mixture of poly-961/4D-lactide copolymer and tricalsiumphosphate (TCP). Design of driver hole is adapted of Linvatec BioScrew implant (K933719, -K952831, K973758). Thread profile is adjusted to fit with bone taps of Linvatec BioScrew implant -(K933719, K952831, K973758). Reference numbers for these new screw versions. These changes are updated in labelling. New trade name to separate it from SmartScrew ACL. This change is updated in labelling. Revision of insert sheet concerning adaption of instrumentation of BioScrew. -