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The TotalTi ACDF 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 TotalTi ACDF 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 TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

The TotalTi ACDF by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The TotalTi ACDF by SAGICO, is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are customizable additively manufactured and available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The TotalTi ACDF 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 TotalTi ACDF by SAGICO implant requires the internal fixation blades to be deployed and is designed to be used with FDA cleared supplemental fixation to properly utilize the device. The TotalTi ACDF 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. MATERIALS: The TotalTi ACDF by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The TotalTi ACDF by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001and traditionally machined titanium alloy anchors lock per ASTM F136. FUNCTION: The TotalTi ACDF by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical region.

The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant 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 SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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

SAGICO IBF System - ARIA Lumbar implants 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SAGICO IBF System - ARIA Lumbar are to be filled with autogenous bone graft material. The SAGICO IBF System -ARIA Lumbar implant is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device. The SAGICO IBF System - ARION Cervical implant is 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 at least six (6) weeks of non-operative treatment. The SAGICO IBF System - ARION Cervical implant is to be filled with autogenous bone graft material and placed via open anterior approach. The SAGICO IBF System – ARION Cervical implant must be used with additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARIA Lumbar 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 IBF System - ARIA Lumbar implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO IBF System - ARIA Lumbar 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. SAGICO IBF System - ARION Cervical implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARION Cervical 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. SAGICO IBF System - ARION Cervical implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. SAGICO IBF System - ARION Cervical 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. SAGICO IBF System - ARION Cervical includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. SAGICO IBF System - ARION Cervical implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (Invibio"") per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IINS R05200, IINS R05400 according to ASTM F560. The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.