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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.