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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the Mahe Perfect Spine - Pedicle Screw System is 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 the thoracic. Iumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) tumor, and (6) failed previous fusion (i.e. pseudarthrosis). In addition, when used as a pedicle screw system placed between L3 and S1, the Mahe Perfect Spine - Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft and with removal of the device after solid fusion is established. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Mahe Perfect Spine - Pedicle Screw System is intended for use in skeletally mature patients and pediatric patients for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) tumor resection, and/or (7) unsuccessful previous attempts at spinal fusion (pseudoarthrosis). When intended for anterolateral fixation of the T6-L5 spine the Mahe Perfect Spine - Pedicle Screw System is indicated for: (1) degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e. fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis}, (6) tumor and (7) failed previous fusion.

The Mahe Perfect Spine - Pedicle Screw System consists of a variety of shapes and sizes of rods, hooks, monoaxial and polyaxial screws, cross connectors, as well as appropriate instrumentation. The Mahe Perfect Spine - Pedicle Screw System components are fabricated from titanium alloy per ASTM F136. The system is sold non-sterile, the products have to be sterilized prior to use.

The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.

Mahe Fixation Plate and Screw System consists of various shape and sizes plates featuring compression and locking or non-locking holes, fullthreaded-cortical, short threaded-cancellous, locking or non-locking, cannulated, self-tapping or non-self-tapping screws, compression and dynamic screws, implantable K-wires, pins, washers, and appropriate instrumentation. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in following models available: Tubular Plates, Reconstruction Plates, Cloverleaf Plates, Calcaneus Plates, Anatomical Plates, Clavicula Hook Plates, Small Fragment, Locking Plates, and DHSP/DCSP Screw Plates. The thickness of the plates varies from 1.2mm to 10mm; the length varies from 26mm to 317mm; and the number of the holes varies from 2 to 22. The screw implants are in three different diameter sizes (2.7mm, 3.5mm, and 4.0mm) and the K-wire implants are in various lengths (from 70mm to 310mm) and diameter sizes (from 0.8 to 3mm) available. The system is sold non-sterile, the products have to be sterilized prior to use.