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EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EOVIA Calcium Phosphate Ceramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.

EOVIA is a synthetic, resorbable calcium phosphate bone void filler. It is an osteoconductive material, which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range between 200-500μm. EOVIA is available in granule or rods shapes.

ORIA Top Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Top Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Top Clip System includes components made from commercially pure titanium and titanium alloy described by ASTM Standards F67 GR2 and ASTM F136, respectively. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle screws, set screws, top locking clips and rods.

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: lumbar, thoracic, and pedicular hooks; sacral screws; pedicle screws; set screws; locking nuts; rods in various lengths; connectors with set screws (sacral, transverse, lateral); connecting elements; instruments and sterilizer trays.

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are: - having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; - receiving fusions using autogenous bone graft only; . - having the device fixed or attached to the lumbar and sacral spine; and - . having the device removed after the development of a solid fusion mass. MNI - Posterior pedicle systems are 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 (T-10 - S1/2): - degenerative spondylolisthesis with objective evidence of neurologic impairment . - fracture - dislocation - . scoliosis - kyphosis - . spinal tumor - failed previous fusion (pseudarthrosis) .

The ORIA CLARIS includes implantable components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system to fit the patient's individual anatomical and physiological requirements. Selection of the necessary components is addressed in the surgical protocol. The titanium components are made of surgical implant grade CP Titanium and titanium alloy (6al4Vti). The basic system components include: Connectors, Nuts & Locking Screws, Rods, Crosslinks, Pedicle Screws, Sacral Screws, Unique Instrumentation. The system consists of a series of alloy compatible parts from which various spinal assemblies or constructs may be fashioned. Specially designed connectors, interconnection mechanisms incorporating nuts, screws; longitudinal members (rods) and/or transverse connectors, sacral screws and pedicle screws are offered. The levels of attachment (depending on specific indication) are lumbar and thoracic spine, and the sacrum and may only be used posteriorly.

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks: Sacral screws: Pedicle screws: Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The ORIA ZENITH is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. WARNING: The ORIA ZENITH is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The ORIA ZENITH is a cervical plate system consisting of plates and screws manufactured from titanium alloy (ASTM F 136). Plates are available in a variety of lengths. Fixed and variable screws are available in a variety of lengths and diameters of 4.0 and 4.5mm. A self-tapping version of each screw is also available.

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.