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The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: - 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 When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors and associated surgical instruments. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. RIPLEY SPINAL SCREW SYSTEM BY SAGICO is designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Titus Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titus Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

The Titus Titanium Cervical by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The Titanium Cervical by SAGICO, is intended to be used at one disc level from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Titus Titanium Cervical by SAGICO incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The Titus Titanium Cervical by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The Titus Titanium Cervical by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.

The SAGICO Spinal System - Lucas Expandable Lumbar by SAGICO are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO are to be filled with autogenous bone graft material. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO must be used with the additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

LUMBAR: The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. CERVICAL: The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. MATERIALS: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO, are implants that are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (InvibioTM) per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IJNS R05200, IJNS R05400 according to ASTM F560. FUNCTION: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.