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The EndoLIF® Delta-Cage and DoubleWedge-Cage are intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with autogeneous bone and implanted via a posterior or posteriolateral approach. The EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment with an EndoLIF® cage.

The EndoLIF® devices are interbody fusion devices that have a hollow center chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The product family includes cages of a variety of lengths, widths, heights, and lordotic to suit the individual pathology and anatomical conditions of the patient. The device footprint allows for posterior or posterolateral surgical approaches for insertion. All implant components are made from titanium alloy Ti6A14V ELI using electron beam melting additive manufacturing technology. The EndoLIF® product family is being expanded to include the Delta-Cage and DoubleWedge-Cage implant configurations. The product family also includes instruments to allow for implant size trialing and insertion. The EndoLIF® devices are provided in sterile form. All implants are intended for single use only.

The joimax® Intracs® m Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures. The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as: · Transforaminal procedure • Interlaminar procedure

The joimax® Intracs® em System is a surgical navigation system based on electromagnetic (EM) tracking technology, designed specifically for applications in minimally invasive spine surgery. The system displays instrument position relative to the patient's anatomy.

The Percusys® Plus Pedicle Screw System is intended to provide immobilization 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, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Percusys® Plus Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws and rods. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Percusys® Plus Pedicle Screw System is provided in sterile form. All implants are intended for single use only.

The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.

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joimax® Bipolar Electrosurgical Instruments The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures. joimax® Monopolar Electrosurgical Instruments The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue. The joimax® Electrosurgical Instruments use Radio Frequency (RF) energy to induce thermal effects on tissue. The radio frequency is generated by high oscillating electrical current received from a commercially available RF generator. The joimax® Probes are available in both monopolar and bipolar probe configurations. All joimax® Probes are designed for specific use with joimax® Handpieces. The joimax Handpieces can be used with compatible commercially available surgical generators.

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

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The THESSYS Multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.

A multi-channel endoscope having working channel and/or irrigation channel(s), used to visualize the operative site. The THESSYS MULTISCOPE consists of light transmitting optical fibers and an image transmitting fiber bundle and lens, or a rigid rod-lens transmitting images. It has one or two irrigation channels and a working channel contained within a rigid stainless steel envelope.