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The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies) 2. Spondylolisthesis 3. Spinal stenosis 4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 5. Pseudoarthrosis 6. Revision of previous surgery

The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The device has a shape which restores the intervertebral height and lordosis. The Elegance® Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw's holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are self-drilling or self-tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance® plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy.

The Idys® PLIF cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L3 to S1. The Idys® PTLIF, Idys® TLIF cages are indicated for use with autogenous 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 implants may be implanted via a posterior and/or transforaminal approach. 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 Idys®-LIF cages, which have various widths and heights, are designed for use as a lumbar interbody fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device can contain one or more 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 a rough surface which interact with the surface of the vertebral endplates and help in resisting back out. The Idys®-LIF cages are made of compliant ASTM F2026 polyetheretherketone (PEEK) with markers made of compliant ASTM F560 Tantalum for PLIF and PTLIF, made of compliant ASTM F560 Tantalum and made of compliant ASTM F136 Titanium alloy for TLIF. It is essential to insert implants with instrumentation specifically designed for this purpose.

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 System is indicated 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 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 modified Erisma® Lp Spinal Fixation System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System device (K240872). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure. The cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, Offset Connectors, screw sets and associated instruments. Further, the implants used in the cleared Erisma® Lp Spinal Fixation System device and modified Erisma® Lp Spinal Fixation System are both made of Ti6Al4V alloy per ASTM F136. The modified Erisma® LP MIS is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® LP MIS device (K162367). The Erisma® LP MIS device is indicated 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 subject of this submission is the extend to the Erisma® Lp Spinal Fixation System and the Erisma® LP MIS, with the addition of new components: 'Uniplanar Screws'

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® Deformity Spinal System is indicated 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 lumbarfirst sacral (L5-S1) vertebral joint; deformities (Scoliosis); spinal tumor; failed previous fusion (pseudarthrosis). 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 System is indicated as an adjunct to fusion for the following indications: Degenerative 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® Deformity Spinal System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Lp Spinal Fixation System device (K170163). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure. The Erisma® Deformity Spinal System device is an extension of the already cleared Erisma® Lp Spinal Fixation System. The cleared Erisma® Lp Spinal Fixation System are composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, screw sets and associated instruments. Further, the implants used in both the cleared Erisma® Lp Spinal Fixation System device and Erisma® Deformity Spinal System are made of Ti6Al4V allov per ASTM F136. The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System, with the addition new components 'Closed Offset Connectors' and commercialization of the 'Open Offset Connectors' provided in the Erisma® Deformity Spinal System range.

The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys®-C ZP 3DTi device must be filled with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

The Idys® C ZP 3DTi device consists of a cervical intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy and is to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The Idys® C ZP 3DTi device consists of cages and screws, as well as associated surgical instruments.

The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies) 2. Spondylolisthesis 3. Spinal stenosis 4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 5. Pseudoarthrosis 6. Revision of previous surgery

The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels. The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.

The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys@-C ZP 3DTi device must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

The Idys® C ZP 3DTi is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade Titanium alloy and must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no additional supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy.

The Idys® ALIF 3DTi (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 level. 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 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

The Idys® ALIF 3DTi 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 3DTi 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion process between the endplates. The device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys® ALIF 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with bone graft. The insert for fixation of the plate is made of ASTM F2026 compliant polyetheretherketone (PEEK). The screws and plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF 3DTi cages are positioned using a set of surgical instruments common for anterior 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® LLF 3DTi system is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous level(s) 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 level(s). These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. The Idys® LLF 3DTi system is intended to be used with bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation to the integrated plate and screws.

The Idys® LLIF 3DTi is designed for use as a lumbar intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy using an additive manufacturing method and is to be used with bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The cage has a shape which restores the intervertebral height and lordosis. The cage contains two (2) slots to receive the bone graft to promote the fusion process between the endplates. The Idys® LLIF 3DTi is a system intended to be used with a plate and two (2) bone screws, bone graft and supplemental fixation that has been authorized for surgical use in the lumbar spine. The Idys® LLF 3DTi components are made of compliant ASTM F136 Titanium alloy.

Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Erisma®-LP Navigated Instruments are manual, non-sterile, reusable surgical instruments for use with the Medtronic StealthStation™ Navigation System to assist the surgeon in locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of the Clariance Erisma®-LP, Erisma®- MIS pedicle screw implants. The Erisma®-LP Navigated Instruments include the following instruments: Drivers, Tap, Bone Awl, Probes. The instrumentation is designed for use with the Medtronic StealthStation™ Navigation System hardware and software. These instruments are made of medical quality stainless steel according to the ASTM F899 and titanium alloy according to the ASTM F136.