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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 ART2 Spinal Fixation 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 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 ART2 Spinal Fixation 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 ART2 Spinal Fixation System has been developed with the objective of providing the surgeon with an adaptable pedicle screw system in order to carry out posterior pedicle screw fixation of the spine simply, quickly and effectively. It is a modification of the ART Pedicle Screw system (K033150). The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

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).

Otomedics Soft Tympanostomy Tube is a device that is intended to be implanted for ventilation or drainage of the middle ear.

The Otomedics STT is a single flexible tube made of silicone rubber. The internal shape of the shaft is conical with T-shaped external flanges.

The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes. The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.

The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.

The Omega Xp Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by either AC or battery power and can be used with a variety of laser probes. The Omega Xp Laser System is intended to emit energy in the infrared spectrum to provide temporary relief of pain associated with rotator cuff tendonitis. The Omega Xp Laser System is comprised of a Base Unit and select Laser Probes. The Base Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Base Unit by an umbilical cord. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.