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The WAVE O Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The WAVE O cage is an expandable PEEK cage of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The FUSE Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). FUSE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The FUSE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The FUSE is rectangular in shape and it has a honeycomb structure thru the implant in the superior/inferior direction. There is an oval opening in the M/L direction. There is a roughened surface on the superior and inferior surfaces. There are neutral, 4° and 8° lordosis configurations. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered.

SHELL Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. SHELL Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. SHELL Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The WAVE/LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SHELL was especially adapted to the local anatomy in order to secure the surgical result as possible. Its caudal side is flat, its cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The A/P view is trapezoidal. There are x-ray pins at the four edges, which slightly protrude the cage in order to maximize rotational fixation. The LOOP is a banana-shaped implant with optimized tip design and an integrated swivel joint for the instrument fixation. Both factors facilitate the implantation. The radial orientated fixation teeth define the direction of implantation and secure the implant position. LOOP is shaped with a 6° lordosis. The WAVE is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6° lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) Function: The SHELL Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The WAVE Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF). The LOOP Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Transforaminal Lumbar Interbody Fusion (T-LIF).

The ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 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 . - pscudoarthrosis . - failed previous fusion .

The ART Anterior Spinal System consists of a Plate that attaches to the anterior or antero-lateral vertebral body of the thoraco-lumbar and lumbar spine. One place on each vertebral body. The single size plate is attached to the vertebral body with two diverging Ø6.5mm Screws. The superior portion of the plate is U-shaned to receive a Ø6mm Rod. The inner surface of the U-shaped opening of the plate is threaded to receive a Locking Nut. When tightened the Locking Nut firmly secures the Rod to the Plate. In this manner the Rods connect two or more Plates. Sce schematic in Exhibit III. A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system ART Posterior Spinal System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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 hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.

Pedicle Screws, monoaxial and polyaxial, are available in various lengths and diameters. The Screw is connected to Federe Screws, nonoaxian and polyamin, are a in lengths ranging from 40mm to 500mm. The Screw is inserted the Rod Via a Not Connector and inserted in the bone. As a top loading system the Connector has a Uthrough an opening the Rod. The interior of the U-shaped opening in the Connector is threaded to accept a Shaped Opening that accepts the Rod. The Connector. The necessity for rod bending is reduced by the ability to vary the angle between the screw and connector up to 20°. A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel. A Cross Connector, of varying lengths, attaches to the rods to provide rotational stability to the construct. Pedicle, laminar and transverse hooks are also part of the system. The rods attach to the hooks and can be used for single or multiple level fixations.