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The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (TI -L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1). When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are intended for use in the skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. When used in the thoracolumbar spine (T1-L5), the HAWKEYE ™ VBR Spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e.,posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or “teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.

The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable instruments are specifically 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.

The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: · Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); - · Pseudoarthrosis; - · Spondylolysis; - · Spondylolisthesis: - · Spinal stenosis; - Tumors; - · Trauma (i.e. Fractures or Dislocation); - · Deformities (i.e. Scoliosis, Kyphosis or Lordosis); - Failed Previous Fusion The Raven Lumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Raven Lumbar Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). Raven Lumbar Plate System consists of plates and screws manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) 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. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with (4) bone screws provided and the accompanying anterior cover plate assembly. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

The Choice Spine TiGer Shark™ System is indicated for spinal 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). These patients should have had six (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.

The Choice Spine TiGer Shark™ System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, or lateral approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.

The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).

The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetherethertone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582). The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants. The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or "teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. This system includes implants made of PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are intended to provide immobilization and stabilization 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 the 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); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior, non-cervical pedicle, and non-pedicle fixation, the Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors on the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6Al-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes connector and hook components.

The Proliant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

The ChoiceSpine Proliant Posterior Pedicle Screw and Hook Fixation System is a toploading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar, and sacral spine. Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and Cobalt Chrome (Co-28Cr-6Mo per ASTM F1537) in various sizes. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.