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SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.

The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.

The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

The SPICCA Stand-Alone Cervical Fusion Cages are single-use, sterile, PEEK (ASTM F560) anterior cervical interbody fusion cages with integrated Ti-6Al-4V ELI (ASTM F136) screws that are intended to be implanted between two adjacent vertebral bodies as part of single or multilevel Anterior Cervical Discectory and Fusion (ACDF) procedures. The SPICCA Stand-Alone Cervical Fusion Cages which are offered in the SPICCA-SP version and SPICCA-S2 version are offered in a variety of sizes to accommodate various patient anatomies (Note: SPICCA-S2 differ in footprint options and endplate-contacting surface shape). The cages include Tantalum (ASTM F560) radiographic markers and are offered uncoated or coated with titanium plasma spray (ASTM F1580).

The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.

The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion. The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to 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 at the involved level(s). The devices may also be used in patients with pseudarthrosis / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.

The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family including the PLIF Caliber Lordotic, the TLIF Bullet, and the TLIF Camber consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy. The Southern TLIF family implants are offered with straight or curved profiles. The straight profiles include the PLIF Caliber Lordotic (a PLIF) implanted from the posterior approach and the TLIF Bullet (a T-PLIF or straight TLIF) implanted from the transforaminal approach. The curved version is the TLIF Camber (a curved TLIF) implanted from the transforaminal approach. The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Southern TLIF family implants are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The curved TLIF designs include a titanium alloy hinge (Ti-6Al-4V per ASTM F136). The Southern TLIF family implants are provided sterile.

The Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required. The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to 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 at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

The Southern Anterior Screw Fixated Cage (SASCA) is intended to treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion. The SASCA devices are stand-alone devices offered in a variety of sizes to accommodate individual patient anatomy. The SASCA cages are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The fixation screws are manufactured from Ti-6A1-4V per ASTM F136. Note: The subject SASCA device is also labeled in markets outside the United States as the Sasca 2 Anterior Lumbar Standalone Fusion Cage.