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The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spinal stenosis. fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors. The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the indications specified above.

NexLink OCT is the re-design and modernization of the existing OctaFix svstem. The scope of the NextLink OCT Cervical Plating System will include 1) a modular occipital plate, 2) a selection of precontoured rods, 3) hooks and 4) a refined set of instrumentation. The scope of the project is for Next ink OCT to integrate as an option to the current Nex-Link System. The NexLink OCT Occipital Cervical Plating System components are temporary implants that are used to stabilize the spine (occiput-T3) during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.

The Universal Clamp Stainless Steel System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications: - Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis, - Spinal degenerative surgery, as an adjunct to spinal fusions; The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp Stainless Steel System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Ardis™ Spacer is a hollow device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine.

When intended for pedicle screw fixation from T1 -S1, the Sequoia Thoracolumbar Pedicle Screw 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 following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion. As pedicle screw system places between 1.3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established. When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative dise disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion. When intended for anterolateral screw, rod and/or cable fixation of the T6-L5 spine, the indications are degenerative disc disease (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, and/or lordosis), turnor and failed previous fusion. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure. The use of posterior spinal instrumentation in children has been reported in the literature. The Sequoia Spinal System may be used for non-pedicle posterior use in this patient group.

The Sequoia Spinal System consists of various open style screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes titanium spinal pods in varying lengths. Additionally included are screws with a polyaxial design, allowing the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening.

PathFinder - Mini-Open Posterior Approach When intended for pedicle screw fixation from L1-S1, the indications include 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The Abbott Spine, Inc. PathFinder® system is a pedicle screw fixation system designed to allow for use of an open or mini open surgical technique. The approved Pathfinder® system consists of various screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine. The subject device is the result of modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject device shares the same intended use and fundamental scientific technology as the predicate device.

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants. The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior cervico-thoracic spine. The subject devices share the same intended use and fundamental scientific technology as the predicate.

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants. The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.

The Universal Clamp System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions; The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only . The multiaxial screws are not intended to be placed in the cervical spine.

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants. The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.