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OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots. foramina, intervertebral discs and the surrounding spinal structures.

OSI Q System Arthroscopes are rigid, fixed arthroscopes with a wide-angle view and a rod lens imaging system with a fiber optic illumination system to provide visualization of various anatomic structures during diagnostic and operative arthroscopic procedures. OSI Q System Arthroscopes have surgical stainless steel shafts and lens housing for durability and are available with various angles of view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surgical site and surgeon preference. OSI Q System Arthroscopes have a working length of 175.5 mm to 212.5 mm. diameters ranging from 3.1 mm to 5 mm. an angle of view (direction of view) of either 30° or 70°, and a field of view of either 90° or 100°. Visualization sheaths are provided in three designs, with diameters of either 5 mm or 6.1 mm, an angle of view of 0°, 30°, or 70°, and working lengths ranging from 151 mm to 185.5 mm. The arthroscope main body tube, insertion tube, and optic tube are all made from 304 stainless steel. The other patient contacting parts of the arthroscope are the objective window (sapphire), eutectic solder, and USP Class VI epoxy, and are the same materials used in the predicate OSI Arthroscopes (K091398). The visualization sheaths are made from 316 stainless steel. Arthroscopes are provided non-sterile and are reusable. Visualization sheaths are provided sterile for single use only.

The Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears

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The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The TS-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The Titanium-TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The Titanium-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The OutologousTM Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. In addition, the Outologous Spinal Fixation System is intended to provide immobilization and stabilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusions (pseudoarthrosis).

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The TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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