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The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of: • Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; • Revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilized components: • Ligamentous instability requiring implant bearing surfaces with increased constraint; • Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended for implantation with bone cement.

The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components.

The Accin™ Bipolar Head components are intended to be implanted to replace a portion of the hip for: - Fractures of the proximal femur; . - . Non-unions of proximal femoral neck fractures; - Aseptic necrosis of the femoral head; . - Osteo-rheumatoid and post traumatic arthritis of the hip with minimal . distortion of the acetabulum; and - . Salvage of failed total hip arthroplasty. The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

The Accin™ Bipolar Head System consists of a cobalt chrome femoral head with a preassembled polyethylene insert and a snap ring that locks the head into the insert.

The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Avascular Necrosis; The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.

The Accin™ Unipolar Head System consists of a cobalt chrome modular endo prosthesis femoral head.

The Accin™ Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of: Degenerative disk disease (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies); Spondylolisthesis (grade 3 or 4); Trauma (i.e.: fracture or dislocation) ●; Spinal stenosis ●; Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) ●; Tumor; Pseudoarthrosis .; Failed previous fusion. ●. The Accin™ Pedicle Screw System components are intended for non-cervical pedicle fixation of: Spondylolisthesis (grade 3 or 4) .; Trauma (i.e .: fracture or dislocation) .; Spinal stenosis; Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) .; Tumor ●; Pseudoarthrosis ; Failed previous fusion. . These components are single use only and are intended for use in skeletally mature patients.

The Accin™ Pedicle System consists of titanium alloy rods, cannulated, multi-axial and standard screws, locking caps, and cross-connector components. The surgeon uses the components to make a construct for spinal fixation.

The Accin™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scoliosis); pseudoarthrosis; and/or failed previous fusions. The Accin™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

The Accin™ Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine

The Accin™ Hip System components are for use in total hip arthroplasty as a result of: Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip Correction of functional deformity Avascular Necrosis Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results These components are single use only and are intended for implantation without bone cement.

The Accin™ Hip System consists of plasma spray coated titanium alloy femoral component, a cobalt chrome femoral head, a plasma spray coated titanium alloy acetabular shell, bone screws and a polyethylene acetabular insert.