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The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF, SPIRA® Open Matrix LLIF and SPIRA®-O Open Matrix Lateral Anterior Lumbar interbody fusion devices indicated for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis). spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The SPIRA® Anterior Lumbar Spacers are intended to be used with additional FDAcleared supplemental fixation systems. The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers system must be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The Camber Spine Technologies SPIRA-A Integrated Fixation System is indicated for use at one or more levels from L1-S1 as an adjunct to fusion in skeletally mature patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy) spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The Camber Spine Technologies SPIRA-A Integrated Fixation System spacers must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These devices are intended to be used with or without three screws and/or anchors which accompany these implants. These spacers are intended for use with additional FDA-cleared supplemental fixation. In addition, these spacers are intended for stand-alone use in patients with DDD at one or two contiguous levels only when ≤20° lordotic implants are used with three screws per implant. Other configurations of this system are not intended for stand-alone use and must be used with additional FDA-cleared supplemental fixation.

The Camber Spine Technologies SPIRA® Anterior Lumbar interbody fusion devices that have an open matrix design to permit packing with autogenous graft material to facilitate fusion. The subject submission seeks to expand the indications of the existing SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF and SPIRA® Open Matrix LLIF). Additionally, this submission seeks to expand the anterior lumbar spacer options by adding the subject SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers components to the SPIRA® Anterior Lumbar Spacers as well as add the SPIRA®-A Integrated Fixation System. The Camber Spine Technologies SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers are interbody fusion devices with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implants may be inserted from an anterior oblique lateral approach. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The implants are available in a variety of sizes to accommodate varies patient anatomies. The Camber Spine Technologies SPIRA®-A Integrated Fixation System is an anterior lumbar interbody fusion device that has an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion as well as additional fixation options to secure the idsc space. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place, and structural arched to help distribute load across the joint space. The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. Patients with previous non-fusion spinal surgery at the treated level may be treated. Camber Spine Technologies SPIRA® Anterior Lumbar Spacers, SPIRA®-A Integrated Fixation System blocker screws, and bone anchors are additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001. The SPIRA®-A Integrated Fixation System bone screws are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 and 4-screw plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) 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 deqeneration of the disc confirmed by patient history and radioaraphic studies): Pseudoarthrosis: Spondylolisthesis: Spinal stenosis: Tumors; Trauma (i.e. Fractures including dislocation and subluxation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion. The Camber Spine Alcantara Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft 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.

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

The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroliac joint disruptions and degenerative sacroiliitis.

The Camber SI Fixation System is comprised of a single-use implant and reusable instruments. The Camber SI Fixation System implant is intended to be implanted in the undeployed state via a posterior approach into the sacroiliac joint. Once implanted, the anchors are deployed to stabilize the sacroiliac joint. The Camber SI Fixation System implant includes multiple openings to allow surgeons to fill them with autogenous bone graft.

SPIRA® Posterior Lumbar Spacers (SPIRA®-P Posterior Lumbar Spacer, SPIRA®-T Oblique Posterior Lumbar Spacer, and SPIRA®-TA Posterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis), and failed previous fusion (pseudoarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. SPIRA® Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems. SPIRA® Posterior Lumbar Spacers are intended for use with an autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The Camber Spine Technologies SPIRA® Posterior Lumbar Spacers are lumbar interbody fusion devices that have an open matrix design to permit packing with autogenous graft material to facilitate fusion. The subject submission seeks to expand the indications of the existing SPIRA® Posterior Lumbar Spacers (SPIRA®-P and SPIRA®-T) as well as add the subject SPIRA®-TA components to the Camber Spine Technologies SPIRA®-TA Posterior Lumbar Spacer allows the interbody fusion device to be inserted from a transforaminal approach. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The device contains a rotating pin that allows for articulation to accommodate the surgical approach. Patients with previous non-fusion spinal surgery at the treated level may be treated. Camber Spine Technologies SPIRA®-TA device body is additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001-14. The internal device components (locking cap and pivot pin) are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is indicated for use 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. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is intended to be used with additional FDAcleared supplementary fixation systems. The Camber Spine ENZA®- O Titanium Lateral Anterbody Fusion (ALIF) must be used with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The Camber Spine Technologies ENZA®-O Titanium ALIF is a lumbar interbody fusion device that has a hollow chamber to permit packing with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior anchoring plates. These implants may be implanted via an anterior oblique lateral approach. Patients with previous non-fusion spinal surgery at the treated level may be treated. Camber Spine ENZA®-O device body is additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001-14. The internal device components (anchor plates, deployment ram, assembly pin and retention blocking screw) are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136. The internal sheer pin component is manufactured from PEEK per ASTM F2026.

The SPIRA®-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. When used with screws, SPIRA®-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA®-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

The SPIRA®-C Integrated Fixation System cages are interbody cages with integrated screws to provide additional fixation in interbody fusion procedures. The subject submission seeks to add anchors as an option for use for integrated fixation. The SPIRA-C® Integrated Fixation System cages are provided various heights and footprints to accommodate patient anatomy. The SPIRA®-C Integrated Fixation System has spiral supports to allow for a hollow chamber to permit packing with bone graft to facilitate fusion. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. When used with screws as integrated fixation, SPIRA-C Integrated Fixation is a stand-alone cervical fixation device. However, this submission seeks to add anchors as another option for integrated fixation. When used with anchors, the SPIRA-C Integrated Fixation System must be used with supplemental fixation.

The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.

The Camber SI Fixation System is a fusion device consisting primarily of an open architecture 3D generated titanium body to permit bone growth (fusion) throughout the implant. All internal surfaces have a roughened texture. The upper and lower faces have specifically designed surface approximately 0.5 mm thick to provide a trabecular support structure. In addition, the device utilizes a set of two sharpened anchor plates that translate from within the device in slightly angular opposing lateral directions which provide an anchoring system to fixate the implant between ilium and sacrum. The Camber SI Fixation System device has one footprint: 23x26 mm. Implant heights range from 9 to 13mm in 2 mm increments with 8° angulation.

Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System 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® 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

Camber Spine Navigation System contains reusable instruments, provided non-sterile, including inserters, taps, probes, awls, and awl taps. These instruments are intended to be used with the Medtronic StealthStation® Navigation System and its associated NavLock arrays, to assist surgeons in precisely locating anatomical structures for preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery. The instrumentation is designed for use with the Medtronic StealthStation® Navigation System hardware and software. These instruments are made of medical grade stainless steel according to the ASTM F899 and many include a titanium nitride coating per SAE AMS 2444A.

SPIRA®-P Posterior Lumbar Spacers are lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems. SPIRA®-T Oblique Posterior Lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA Posterior Lumbar Spacers (SPIRA-P Open Matrix PLIF, SPIRA-T Oblique Open Matrix TLIF) are lumbar interbody fusion devices used to provide structural stability following discectomy. SPIRA Posterior Lumbar Spacers have different shapes to accommodate posterior and transforaminal approaches.

The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease is defined as intractable radiculopathy and/or myelopathy with hermiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The SPIRA-C Integrated Fixation System must be used with internal screw fixation. The Camber Spine Technologies SPIRA-C Integrated Fixation System must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The SPIRA®-C Integrated Fixation System consists of a stand-alone interbody fusion device with internal screw fixation. The SPIRA®-C Integrated Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two levels from the C2-C3 disc to the C7-T1 disc. The system is comprised of a Titanium Alloy (Ti-6Al-AV ELI) interbody cage and screws. The SPIRA®-C Integrated Fixation System cages are provided in 7 degrees of lordosis, 6-12mm heights, 14-20mm widths and 13-16mm depths. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The SPIRA® C Integrated Fixation System is that has spiral supports to allow chamber to permit packing with autogenous and/ or allogenic bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The bone screws used with this device are provided in self-tapping options, along with variable angle and fixed angle trajectories, and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 12-18mm lengths.