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When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending the ProMIS Fixation System to a single adjacent level.

The ProMIS Extension Rod System (also referred to as PER System) is composed of a fusion rod (Turret™ Rod) with a spherical head at one end and a rod on the other end. The Turret™ Rod's end is connected to a pedicle screw at the adjacent vertebrae to be fused, while the spherical head attaches to the Tulip's head of Premia Spine's pedicle screw of the existing fusion system using a designated Set Screw and a Ring Nut. The spherical head of the ProMIS Extension Rod System is designed to be positioned on Premia Spines' Slender Tulip Polyaxial Pedicle Screws. The Rod is available in two lengths 60 and 75 mm in a diameter of 6 mm. All components of the ProMIS Extension Rod System are made of Titanium alloy (Ti-6Al-4V ELI per ASTM F136).

The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimal invasive (MIS) instrumentation.

The ProMIS™ Fixation System consists of 3 main single use implanted parts: 1. ProMIS™ Fusion Rods: a straight or bent rod of various lengths. 2. Polyaxial Pedicle Screws: cannulated and non- cannulated screw bodies with self-tapping flutes and rounded or self-drilling tips, available in three diameters (5.5mm, 6.5mm, with length ranging from 25 to 60, in increments of 5mm. 3. Setscrew. All components are manufactured from Ti6Al4V per ASTM F136 Rods up to 100mm in length and the Pedicle Screws are provided sterile (gamma irradiated). Rods exceeding 100mm are supplied non-sterile (steam/autoclave sterilization by the end user).

The VersaLink™ Fixation System is intended to provide immobilization 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: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; tracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

The VersaLink™ System consists of 6 Ti-6AI-4V main parts: 1. The VersaLink rod (the Rod); a spinal fixation rod with a dedicated ring end designed to enable robust attachment to the pedicle screw head above the crossbar. 2. Ring nut: dedicated nut designed to be tightened on the Ring Set Screw and firmly fix the VersaLinkTM Rod on the pedicle screw head. 3. VersaLink Ring Set Screw Torx: dedicated setscrews with double thread designed to allow attachment of the VersaLink™ Rod device to the head of the pedicle screw above the crossbar. 4. Crossbar rod: a bent rod designed to fit the average angle of the lumbar vertebra pedicles. It is horizontally attached to two pedicle screws on the same vertebra in order to reduce peak loads by better distributing the loads between the pedicle screws. 5. Polyaxial Pedicle screws 6. Torx Setscrew.

The ProMIS™ Fixation System is 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: 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

The ProMIS™ Fixation System consists of 3 main single use implanted parts: 1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths. 2. Polyaxial Pedicle screws. 3. Setscrew. All components are manufactured from Ti6Al4V per ASTM F136.

The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.

The ProMIS™ Fixation System consists of 3 main parts: - 1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths. - 2. Polyaxial Pedicle screws. - 3. Setscrew. All components are manufactured from Ti6Al4V per ASTM F136.