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PISCES™-SA ALIF Spacers (Standalone Use, With Integrated Fixation) The PISCES™ SA (Standalone) ALIF Interbody System are lumbar 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. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. PISCES™-SA Used with Screws and/or Anchors: When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation. When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation. Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels. PISCES™ ALIF Spacers (Without Integrated Fixation) PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>= 20 lordosis) must be used with at least anterior supplemental fixation.

PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES™ SA interbodies are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.

The Black Diamond™ POCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (TI-T3); traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors in whom if e expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels offixation, the Black Diamond™ POCT Spinal System may be comected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.

The Black Diamond™ POCT Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Black Diamond™ system contains rods in multiple shapes and sizes, polyaxial screws, set screws, rod connectors and transverse connectors. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

PISCESTM-SA ALIF Spacers (Standalone Use. With Integrated Fixation) The PISCES™ SA (Standalone) ALIF Interbody System are lumbar 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. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. · PISCESTM-SA Used With Screws: When used with three (3) screws, interbody devices with a lordotic angle < 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels. Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels. · PISCESTM_SA Used With Anchors When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation. PISCESTM ALIF Spacers (Without Integrated Fixation) PISCESTM ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudatthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.

PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices. When used with anchors or without screws, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES" -SA interbodies are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, anchors, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.

The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.

The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Black Diamond Navigation Instruments are non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually. These instruments are intended to be used within the context and limitations of the indications for use for Osseus Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy Experience StealthStation System S7 (v2.1.0). Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy

The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The implants were developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.

The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis

The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to provide stabilization of the cervical vertebrae for various indications. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The White Pearl Preferred Angle Anterior Cervical Plate is intended to be removed after solid fusion has occurred.

The Osseus Black Diamond Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: 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 Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.