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The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade stainless steel per ASTM 138. The implants are provided sterile. Instrumentation has been designed for use with this implant system.

The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade titanium alloy per ASTM F 136, unalloyed titanium per ASTM F 67, and cobalt chromium alloy per ASTM F 90. The implants are provided sterile. Instrumentation has been designed for use with this implant system.

The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following: · Defect of the pars interarticularis · Spondylolisthesis The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.

The Posterior Cable Screw System consists of screws, cables, and grommets utilized for the correction of pars defects. A construct consists of two cable screws with locking set screws and a cable connecting the two screws. The screws are inserted into the pedicles and the cable is passed around the spinous process between the two screws. The grommet surrounds the cable at the location of the spinous process. The cable is tensioned and the set screws are tightened and fully locked per the surgical technique. The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90. The implants are provided sterile. The Posterior Cable Screw System utilizes Class I manual instruments to facilitate implantation of the device components.

The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The device must be used with supplemental fixation (i.e., lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. When used with the integrated locking plates, it is indicated to be used at one level from L2-L5. When used without the integrated locking plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Ancora system consists of different footprints and heights to provide options that correlate best to an individual's anatomy and pathology. The system offers optional integrated locking plates with corresponding locking pins. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and PEEK Optima LT1 per ASTM F2026 with tantalum markers per ASTM F560. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine. The purpose of this submission is to add implant configurations to the Ancora LLC line of implants, and modify the indications for use so the locking plates are optional fixation devices. Surgical Instruments are also available for use with the system.

The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

The Frontier LLC is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. The body of the implant includes size ranges of 8-16mm wide, 18mm high and lengths of 40-60mm. There are five sizes of locking plates and 5 sizes of corresponding screws. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1. The implant is available with no lordosis built into the implant design.