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The VERTICALE® Triangular Fixation System, when used in combination with the VERTICALE® Posterior Spinal Fixation System, is intended for immobilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® Triangular Fixation System is intended to treat the following conditions: trauma (i.e., fracture or dislocation); tumor, pseudoarthrosis; and failed previous fusion. The VERTICALE® Triangular Fixation System is intended for iliac fixation and must be attached to the VERTICALE® Posterior Spinal Fixation System to treat the conditions listed above. Refer to the labeling for the VERTICALE® Posterior Spinal Fixation System for limitations and instructions for use.

The VERTICALE® Triangular Fixation System consists of iliac screws with a UHMWPE lined slot, a polyaxial head as well as related instruments. The VERTICALE® Triangular Fixation System is intended to be used with VERTICALE® Posterior Spinal Fixation System (K171421). The implants of the VERTICALE Triangular Fixation System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and Ultra-High-Molecular-Weight Polyethylene according to ASTM F648 / ISO 5834-1 and -2.

Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precise locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Silony Medical's VERTICALE® navigation instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures. The VERTICALE® Navigation Instruments include awls, probes, taps, drivers and inserts. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System cleared under K171421. All instruments are made of stainless steel per ASTM F899. The VERTICALE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Silony Medical VERTICALE® Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants. The VERTICALE® Navigation Instruments include awls, probes, taps, and drivers. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System. All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4.5mm to Ø10.2mm. The VERTICALE® Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The VERTICALE Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3): - traumatic spinal fractures and /or traumatic dislocations - instability or deformity - failed previous fusions (e.g. pseudoarthrosis) - tumors involving the cervical/thoracic spine - degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and - degenerative disease of the facets with instability

The VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3). The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation. The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities. The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy. Implants delivered by the manufacturer in a sterile condition may not be sterilized. They are intended for single use.

The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The FAVO S-TLIF (straight transforaminal lumbar interbody fusion) Cage is an implant for primary stabilization and restoration of physiological lordosis in the lumbar and thoracic spine. The cage is designed for transforaminal approaches. The aim is to eliminate discogenic back pain, correct deformities, remedy instabilities, restore intervertebral height, restore physiological lordosis, and provide biomechanical support for bone fusion in the disc space. The system is designed for use with autogenous bone graft to facilitate fusion and must be used with additional stabilization. For posterior lumbar stabilization, Silony Medical recommends the use of a posterior spinal fixator (e.g., the VERTICALE system). The devices are to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF is manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and ASTM F3001. The FAVO S-TLIF implant is delivered in a sterile condition and can be used without any further preparations. The cages are packaged in accordance with EN ISO 11607 Party 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy. Implants delivered by the manufacturer in a sterile condition may not be sterilized.

The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.

The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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 or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open posterior 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 ROCCIA PLIF cage is manufactured from polyetheretherketone (PEEK) according ASTM F2026. The cage is equipped with a chamber system that can be filled with autogenous bone graft. The integrated x-ray markers which are made of tantalum according ASTM F560 enable a presentation of the implant during insertion and postoperative control examinations. The ROCCIA PLIF cage is available in different sizes and angles. The implants are single use devices. The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA PLIF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of the multiple implantation procedure. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.

The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment. The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12- L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The ROCCIA TLIF and ROCCIA ALIF Cage implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The ROCCIA® Transforaminal Lumbar Interbody Fusion (ROCCIA® TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ROCCIA® ALIF) cages are implants for the primary stabilization and restoration of the physiologic lordosis of the lumbar and thoracic spine. Subject device implants are manufactured from Titanium Alloy Ti6Al4V ELI per ASTM F136. The ROCCIA® TLIF and ROCCIA® ALIF cages are offered in a variety of sizes to facilitate a variety of patient anatomies. The ROCCIA® instrumentation is ergonomically appropriate and designed as modular components. The instruments are designed to be used with the ROCCIA® Transforaminal Lumbar Interbody Fusion (TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ALIF), and are made of materials commonly used to manufacture medical device instruments. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.

The VERTICALE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® MIS metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The VERTICALE® System is a posterior fixation system for stabilizing the thoracic, lumbar and sacral spine. The VERTICALE® System is a modular, versatile fixation system consisting of pedicle screws, iliac screws, revision screws, hooks and rods for the fusion of treated spinal segments. The pedicle screws are available in a range of sizes, and in solid, cannulated and fenestrated designs, which when used in combination with the rods, can be used for a range of indications. The pedicle screws and hooks are manufactured from titanium alloy and the rods, from titanium alloy or cobalt chrome alloy. The VERTICALE® System comprises modular ergonomically designed, bi-functional two-in-one (2 in 1) instruments with modular handle options. The VERTICALE® System also offers a set of minimal invasive instrumentation (MIS) to facilitate minimally invasive implantation of the components. The VERTICALE® System is color coded by diameter for ease of identification. The VERTICALE® implants are manufactured from Ti6Al4V ELI conforming to ASTM F136 and CoCrMo conforming to ASTM F1537. The VERTICALE® System specific instruments are manufactured from materials conforming to ISO 16061 and ASTM F899. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.q., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy. The cage has a large cylindrical hollow in the middle which can be filled with bone material. The cage has numerous threaded holes that allow for correct placement of the cage. The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions. The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA MultiLlF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures. The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.