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The SIMPLEX Cervical Fixation System is intended for anterior screw fixation of the cervical spine. Indications for use include: - degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. - spondylolisthesis - trauma (i.e., fracture or dislocation) . - spinal stenosis - deformities or curvatures (i.e., scoliosis, kyphosis, and/or fordosis) - tumor - pseudoarthrosis - failed previous fusion Warning: "This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."

The SIMPLEX Cervical Fixation System consists of plates and is used to build a spinal construct. The purpose of the SIMPLEX Cervical Fixation System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.

Radix Cervical Plate is intended for anterior screw fixation of the cervical spine. Indications for use include: - degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - spondylolisthesis - trauma (i.e., fracture or dislocation) - spinal stenosis - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - tumor - pseudoarthrosis - failed previous fusion

The Radix Cervical Plate is a one or two level plate that is secured to the anterior cervical vertebral bodies with unicortical bone screws. The plate is available in twelve lengths ranging from 38mm to 60mm in lengthe. It has six holes to receive the bone screws. The screw holes allow variable angulation of the screws. Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The acrews are 03.9mm and are available in five lengths, 10mm to 18mm. The self-tapping thread of the screws eliminates are ed or preliminary tapping.

The UNIMAX Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions. As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Pisharodi Surgicals, Inc. UNIMAX Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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 spine, When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the UNIMAX Pedicle Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The UNIMAX Pedicle Screw System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions. As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The UNIMAX Pedicle Screw System consists of pedicle screws (K014302) vertical, washers, nuts and horizontal plates. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The additional component that is the subject of this Special 510(k) submission is the Offset Horizontal Plate. Its purpose is to provide rigidity to the spinal construct similar to the horizontal plate cleared on K014302.

The Universal MultiAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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 spine: (1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (6) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis). " When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The UNIMAX Pedicle Screw System consists of plates, bolts, screws and is used to build a spinal construct. The purpose of the UNIMAX System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. The components and instruments needed for this system are described in the Surgical Technique Manual. The UNIMAX Pedicle Screw System components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM standard F-136. The UNIMAX components will be provided non-sterile.