Search Results

Peridot-PT Anterior Cervical Intervertebral body fusion System: The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-PT Anterior Cervical body fusion system is designed for use with autogenous and or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Peridot-PT Intervertebral body fusion system: The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body 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 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Peridot-TD Anterior Cervical Intervertebral body fusion system: The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The Peridot-TD Intervertebral body fusion system: The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fussion 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 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system: The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 degree) the form of supplement fixation should be an anterior plate system. The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system: This product is intervertebral fusion device manufactured from poly-ether-ether -ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a 0.5 ~ 1.0 micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cage holders are made of titanium alloy as per ASTM F136. The device have a central canal for receiving autogenous bone graft and offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. Designed to treat cervical and lumbar degenerative disc disease, the platform consists of Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. Tantalum marker on the cage permits the identification of cage position and allows post-operative assessment. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are intended to be used with supplement spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.

Peridot-PT Anterior Cervical Intervertebral body fusion System The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Peridot-PT Intervertebral body fusion system The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body 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 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 decree) the form of supplemental fixation should be an anterior plate system. The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

The Peridot-EX Expandable Intervertebral body fusion system is indicated for intervertebral body 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 radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems and anterior screw and anterior screw and rod systems). The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment with an intervertebral cage. Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.

The Peridot-EX Expandable Intervertebral body fusion system is various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. It is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and 3D Printing manufactured from titanium power (Ti-6AI-4V ELI) as described by ASTM F3001. The Peridot-EX Expandable Intervertebral body fusion system expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. All implants are intended for SINGLE USE ONLY and should not be reused under any circumstances. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.

Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body 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 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136. The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation. The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body 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 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136. The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system). The implant cages are supplied sterilized. The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation. The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

Peridot-PT Anterior Cervical Intervertebral body fusion System The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Peridot-PT Intervertebral body fusion system The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body 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 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot-PT Cages are a comprehensive portfolio of 3D-pri interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The implant cages are supplied sterilized. The Peridot-PT Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

Peridot Spinal Interbody System - Cervical The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion with supplemental fixation indicated for cervical fusion procedures. Peridot Spinal Interbody System - Lumbar The Peridot Lumbar Spinal Interbody system are indicated for intervertebral body 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 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. The Peridot Lumbar Spinal Interbody system are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

This product is intervertebral body fixation devices intended for use as an aid in spinal fusion. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile. The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instrument supplied. This product is intervertebral body fixation devices intended for use as an aid in spinal fixation. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile. The devices consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system. The device must be used in combination with the dedicated instrument supplied.

The Prase-C Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), · spondylolisthesis, · trauma (i.e. fractures or dislocations), · tumors, · deformity (defined as kyphosis, lordosis, or scoliosis), · pseudoarthrosis, · failed previous fusion, · spinal stenosis.

The Prase-C Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. The plates are offered in one-level, two-level, three-level, four-level, five-level fusion configurations. In addition, one level plate consists of a four hole for screw insertion and a two-hole and three-hole for screw insertion. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.

Prase PEEK Anterior Cervical Interbody Spacer is 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. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Prase PEEK Anterior Cervical Interbody Spacer is intervertebral body fixation devices intended for use as an aid in spinal fusion. The Prase PEEK Anterior Cervical Interbody Spacer is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile. The device is supplied with their specific instruments. The specific instruments are supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instruments supplied.

The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - · trauma (i.e. fractures or dislocations) - · tumors - · deformity (defined as kyphosis, lordosis, or scoliosis) - · pseudoarthrosis - · failed previous fusion - · spinal stenosis

The Prase-AP Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, five-level fusion configurations. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.