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The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or ioint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Y-Knot® All-Suture Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.

The D4000/D4000A System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.

The D4000/D4000A Drive System console functions as a powered instrument console for driving powered instruments and accessories used in the cutting of soft tissue and bone at the surgical site. The D4000/D4000A Drive System console is a non-sterile device and must be located in a non-sterile area of the operating suite. Additionally the D4000A console offers an irrigation pump that, when used with tubing sets, provides a sterile fluid supply to the blades, burs, and drill bits, at the surgical site, for lavage and cooling. The handpiece, handpiece cord, and irrigation tube sets are sterile. The handpiece is used in the sterile field with the cord connected to the console. The irrigation tube set is used on the handpiece in the sterile field with the cassette connected to the console. The footswitch is non-sterile and placed on the floor. The console provides two handpiece drive ports that are used with a variety of handpieces. Handpiece functionality can be controlled directly by the handpiece, and/or by a corded footswitch or wireless footswitch. Handpiece speed, direction, user settings, irrigation flow rate, and footswitch settings are controlled with the touch-screen displays. The D4000/D4000A is a rebranded update to the Advantage Turbo Drive System (D3000), which shares the same intended use, indications for use, conditions of use, and fundamental scientific technology with the predicate device. The D4000/D4000A powers a reduced set of the same handpieces, to the same performance specifications, as the D3000. Where applicable, these handpieces can also be activated by the same footswitches used in the previous system. The D4000/D4000A software was rewritten in order to accommodate the new internal circuitry layout and to support additional integrated components (i.e. touchscreens, wireless footswitch transceiver, etc.) as well as to send direct signal to 24k when shaver is operating. Further, the D4000 and D4000A are the same device except for the fact that, like the D3000, the D4000A incorporates a low-flow purpose of optional handpiece irrigation. The D4000A also includes a "Prime Button" on the front panel that is associated with the low-flow pump.

The GENESYS PressFT Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The ConMed Linvatec GENESYS PressFT™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of 96L/4D copolymer + B-TCP and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is bioabsorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.

The NANO™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The ConMed Linvatec NANO™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of medical-grade PEEK and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is non-absorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.

The Y-Knot™ All-Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Y-Knot™ All-Suture Anchor is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter device. This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by one suture strand. The flat suture and the single suture strand are folded back on themselves at the distal end of the disposable inserter. The disposable inserter device has a forked shaped distal end, stainless steel shaft, with an ABS handle, that is provided sterile, for single use and is removed at the end of the repair leaving behind an all suture construct. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the all-suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The suture anchor configuration is supplied sterile, single use, preloaded onto a disposable driver. The disposable driver is composed of a 300 series surgical grade stainless-steel shaft with an ABS handle. Additional surgical instruments, including a drill bit and drill guides, are Class I, sterile, single-use devices intended for transient use during orthopedic procedures.

The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and betatricalcium phosphate (ß-TCP). The Genesys Matryx maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing. The Genesys Matryx completes resorption within several years. Resorption also depends on patient variables. The Genesys Matryx need not be removed prior to revision surgery, if such is needed. The Genesys Matryx is sterile and non-collagenous.

The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

The ConMed Linvatec Sequent™ Meniscal Repair Device is an all-inside meniscal repair device that sequentially deploys implants and suture. This device allows the surgeon to generate multiple stitches in order to create fixation points along a soft tissue tear. The hand held, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The implant encompasses a cleat which retains the suture and allows the knotless feature.

The ConMed Linvatec CrossFT™ BC Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The ConMed Linvatec CrossFT™ BC Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors, manufactured of 96L/4D PLA co-polymer + β-TCP and two (2), or three (3) Hi-Fi® sutures manufactured of polyethylene and polypropylene. The device is bioabsorbable and is available in sizes between 4.5mm to 6.5mm diameter and 17mm lengths. A disposable driver is included to implant the suture anchor.

The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The proposed device is a bioabsorbable push-in (press fit) suture anchor that is preloaded on a disposable inserter device with one or two non-absorbable. braided, polyethylene sutures. The proposed device is manufactured from 100% Poly L-lactic Acid with colorant D&C violet #2. The polymer is inert and noncollagenous through the absorption process. The device dimensions are 2.9mm diameter and 10.75mm in length.

ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization. The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size: (list of instruments provided) Sterilize the Hip Arthroscopy Master Tray using the following parameters: (steam sterilization parameters provided) The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces. Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments. Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters. (steam sterilization parameters provided)

ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitate sterilant penetration, evacuation and drying, These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although these trays are reusable they will not be serviced or repaired. ConMed Linvatec Anodized Aluminum Sterilization Trays are available under various trade names and in various sizes and tray configurations. Interior structures of the trays have the ability to separately hold each individual instrument during the entire duration they are in contact with the trav.