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The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.

The Idys™ ALIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine. The Idys™ ALIF TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.

The Idys™ TLIF TiVac cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis 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 devices are intended for intervertebral body fusion, and are intended to be used with supplementation, which has been cleared by FDA for use in the lumbar spine.

The Idys™ TLIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine. The Idys™ TLIF TiVac cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The device has to be used with autograft. The superior and inferior surfaces of the implant are designed with "teeth" to help prevent the device from migrating once it is positionally, the rough plasma-sprayed titanium surface interacts with the surface of the vertebral endblates and helps resist back out. The Idys™ TLIF TiVac cages are made of compliant ASTM F2026 polyetheretherketone (PEEK Optima®) with markers made of compliant ASTM F560 Tantalum and are coated with plasma-sprayed titanium compliant with ASTM F1580. Idys™ TLIF TiVac cages are positioned using a set of surgical instruments common for transforaminal lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

The Idys™ ALIF (Anterior Lumbar Integrated Fusion) System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF System should be used with the integrated fixation screws provided. The Idys™ ALIF System is intended to be used with autograft.

The Idys™ ALIF System is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) and is to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates and helps resist back out. The Idys™ ALIF System is connected to a plate with four screws for a standalone implantation. The Idys™-ALIF System are made of ASTM F2026 compliant polyetheretherketone (PEEK) and markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy.

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal Fixation System is indicated as an adjunct to fusion for the following indications: - Deqenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic . studies): - . Degenerative spondylolisthesis with objective evidence of neurologic impairment; - Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; . - Fracture ● - . Dislocation - Scoliosis . - Kyphosis . - . Spinal tumor - . Failed previous fusion (pseudarthrosis)

The Erisma® LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists in the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure. The Erisma® LP spinal system is composed of rods (straight or pre-bent) fixed on the spine with pedicle screws. The Erisma® LP includes monoaxial and polyaxial pedicle screws (cannulated or not), monoaxial and polyaxial pedicle screws with breaking tabs, as well as transverse link which connects two rods altogether. The implants used in the Erisma® LP system are available in a variety of diameters and lengths to accommodate patient anatomy and are made of medical grade titanium alloy per ASTM F136 or cobalt-chromium allov per ASTM F1537. The Erisma® LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine.

The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: - Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), - Degenerative spondylolisthesis with objective evidence of neurologic impairment, - Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint, - Fracture, - Dislocation, - Scoliosis, - Kyphosis, - Spinal tumor, - Failed previous fusion (pseudarthrosis).

The Erisma® LP MIS device is intended to be used for the surgical treatment of spinal pathologies by percutaneous access. The treatment consists of the stabilization of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure. The Erisma® LP MIS consists of cannulated extended pedicle screws and straight or pre-bent rods that can be used via posterior percutaneous surgical approach to provide the immobilization and the stabilization of spinal segments in mature patients as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar and sacral spine. The components are available in a variety of diameters and lengths to accommodate patient anatomy and are made from ISO 5832-3 or ASTM F136 medical grade Titanium alloy. The Erisma® LP MIS also contains surgical instruments common for posterior percutaneous spinal fixation approach. The primary purpose of this submission is to extend the breakoff tabs of the pedicle screws to allow for minimally invasive surgery.