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When used with the integrated fixation and as a standalone system: The Genesys Spine AIS-C II Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach. When used without the integrated fixation: The Genesys Spine AIS-C II Cervical Interbody Fusion System is indicated 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. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C II Cervical Interbody Fusion will be offered in various device configurations based on surgical approach and patient anatomy. The AIS-C II System has two interbody options: Regular or Standalone. The Regular Cervical Interbody System does not require the use of Anchors but is designed for use with supplemental fixation (i.e., cleared cervical plating system). The Standalone Cervical Interbody System requires the use of Anchors for integrated fixation. This version includes an integrated cam lock mechanism and various sizes of anchors. The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies. After anchor deployment, a cam lock key is used to turn the lockwise) to engage the cam lock and secure the anchors. When engaged (closed), the wings of the cam lock cover the anchor channels and provide a backing plate for the anchors. The subject and predicate devices are based on the same technological characteristics: Integrated fixation anchors provide additional biomechanical support to the interbody. lmplant materials are identical: PEEK, Titanium 6AL-4V ELI alloy, and tantalum. A single inserter can be used to position the interbody and deploy the anchors.

The Genesys Spine Sacroiliac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in SIros and SIros O procedures, in which the use of stereotactic surgery may be appropriate, and where reference to anatomical structures, such as the pelvis or vertebra, can be identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.

The Genesys Spine Sacrolliac Joint Fusion with Navigation consist of instruments compatible with the Medtronic O-arm® Imaging System and StealthStation™ Navigation System to assist the surqeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medtronic O-arm® Imaging System and StealthStation™ Navigation System 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 the spine or pelvis, can be identified relative to images of the anatomy. The Genesys Spine Sacrolliac Joint Fusion System consists of implants designed to secure the sacroiliac joint and minimize micromotion to enable bony fusion. All Implants are cannulated and self-tapping; they are offered with different diameters and lengths to accommodate variations in patient anatomy and surgeon preference. The Slros OTM Sacrolliac Joint Fusion System implants are manufactured from implant grade titanium (Ti-6AL-4V ELI).

When used with the integrated fixation and as a stand-alone system: The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach. When used without the integrated fixation: The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is indicated 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 discogenc pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine 3DP Als-C II Cervical Interbody System includes 3D-Printed (3DP) titanium interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The interbody that utilizes supplemental fixation may be used as a stand-alone that is implanted with two (2) titanium alloy anchors. This version includes an integrated cam lock mechanism and various The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies after anchor deployment. After anchor deployment, in order to engage the cam lock key instrument is used to turn the lock (counterclockwise direction) from an open to closed position. When closed, the wings of the cam lock slide over the anchor channels and provide a backing cover for the anchor and anchor channels. Al interbodies and anchors are made from Ti-6Al-4V ELI titanium alloy. The cam lock is made out Ti-6Al-4V ELI titanium alloy with a PEEK washer. 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 cervical screws) may be needed.

The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.

When used with the internal fixation and as a stand-alone system: The Genesys Spine 3DP Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach. When used without the internal fixation: The Genesys Spine 3DP Cervical Interbody Fusion System is indicated 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. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine 3DP Cervical Interbody System includes 3D-Printed (3DP) titanium interbodies. The 3DP Cervical Interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The version that utilizes integrated fixation may be used as a stand-alone cervical device that is implanted with two (2) titanium alloy anchors. All interbodies are made from Ti-6Al-4V ELI titanium alloy. The standalone version includes an integrated locking mechanism and various sizes of anchors which are all manufactured from Ti-6Al-4V ELI titanium alloy. 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 cervical screws) may be needed.

The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.

The Genesys Spine Binary Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Genesys Spine Binary Lumbar Plate System consists of an assortment of plates and screws. The Binary Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136.

The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Genesys Spine's Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micromotion in order to enable bony fusion. All screws and anchors are cannulated and self-tapping; they are offered with different diameters (up to 13.5mm), lengths (up to 70mm), and styles to accommodate variations in patient anatomy and surgeon preference. Fusion across the graft space can be aided by the addition of bone graft material to the lumen of each screw; fenestration in each screw allow for direct allograft apposition across the sacroiliac joint. Dual thread screws and fully threaded screws provide joint compression by utilizing a compressive thread pattern. Optional Washers are included to aid in conforming to patient anatomy and to help distribute the load onto a larger area. All implants are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI). The delivery system uses guide pins for accurate surgical placement into pre-drilled bone. All implants will be provided non-sterile and are intended for single use only.

The Genesys Spine Binary Anterior Cervical Plate System 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 C7). 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), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

The Genesys Spine Binary® Anterior Cervical Plate System components are temporary implants used to stabilize the cervical spine during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology. The Genesys Spine Binary® Anterior Cervical Plate System consists of multi-segmented titanium/nitinol bone plates of various sizes and lengths, titanium bone screws in various diameters and lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws into the anterior surface of adjacent cervical vertebrae. Fixation of the screws to the plate is accomplished by seating into the screw securement mechanism.

The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors. 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 cervical screws) may be needed. The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.