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The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.

The Wolff's Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: • Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; - · Spondylolisthesis; - Spinal Stenosis: - · Trauma (including fractures); - · Tumor; - · Deformity (i.e., scoliosis, kyphosis, and/or lordosis); - · Pseudoarthrosis; and - · Failed previous fusions

The Spinal Simplicity Wolff's Law Anterior Cervical Plate System is a dynamic cervical plate designed for the anterior cervical spine (C2-C7). The Wolff's Law Plate System consists of one-level plates in multiple lengths with both fixed- and variable-angle screws. The plates are translatable and use a nitinol Compression Element to provide continuous compression at each level. The Wolff's Law Cervical Plate consists of components made from titanium alloy Ti6Al4V ELI per ASTM F136 and superelastic nitinol per ASTM F2063. The fixed and variable screws are made from Titanium alloy Ti6Al4V ELI per ASTM F136. The Anterior Cervical Plate System is provided to the end-user sterile and is single use.

The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-SI Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.

The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1). The Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: · Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or · spondylolisthesis. The Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1). The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1). The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: - · Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or - · spondylolisthesis. The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman MIS Fusion Plate Implants consist of bilateral Plates and a Body/Post that connects the Plate components include several gripping features for attachment of the spinous processes. The Minuteman MIS Fusion Plate Implants are available in multiple sizes to accommodate varying patient anatomy. The Minuteman MIS Fusion Plate Implants are made from Ti6A4V and Ti6A4V ELI. The HA Minuteman MS Fusion Plate have an additional hydroxyapatite coating on the distal regions of the device.

The Liberty SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Liberty SI Lateral Implant System is a minimally invasive sacroliac joint fusion implantation across the joint space (i.e., the implant transfixes the Sl Lateral Implant System is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is partially coated with hydroxyapatite (HA) per ASTM F1185. To accommodate varying patient anatomy, the Liberty Sl Lateral Implants are available in multiple diameters and length offerings. The Liberty Sl Lateral Implants consist of a cannulated central threaded body that has deployable Wings and a Compressive Body. Using the designated instrument system, one or two implants may be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The Liberty SI Lateral Implants are single use devices that are provided sterile.

The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • degenerative disc disease (DDD) (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1). The Minuteman G1 (Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Minuteman G1 (Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1). The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft may be implanted via a lateral transverse approach (L1-S1). The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • degenerative disc disease (DDD) (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman MIS Fusion Plate Implants consist of bilateral Plates and a Body/Post that connects the Plate components include several gripping features for attachment of the spinous processes. The Minuteman MIS Fusion Plate Implants are available in multiple sizes to accommodate varying patient anatomy. The Minuteman MIS Fusion Plate Implants are made from Ti6A4V and Ti6A4V ELI. The HA versions of the Minuteman MS Fusion Plate Inplants have an additional hydroxyapatite coating on the distal regions of the device.

The Edge upper cervical 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 (C1 to C7) and the thoracic spine (T1 to T3): · Traumatic spinal fractures and/or traumatic dislocations; - · instability or deformity: - · failed previous fusions (e.g., pseudarthrosis); - · tumors involving the cervical/thoracic spine; · degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and · degenerative disease of the facets with instability. The Edge UCS is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Edge UCS is intended for use only with the Innosys Anax™ OCT Spinal System.

The Edge UCS consists of a main body that clamps on to the posterior arch of C1 to provide fixation and stability. The Edge UCS is then connected to the Innosys Anax OCT instrumentation using polyaxial rods to form a posterior cervical construct, similar to that of the predicate devices. The Edge device is an additively manufactured clamp composed of two fixation jaws superior to the C1 posterior arch, an inferior jaw base, and two receiving joints for polyaxial rods. The Edge UCS accommodates varying patient anatomy by providing three implant sizes. The Edge UCS is additively manufactured from titanium alloy Ti6Al4V ELI and is designed with areas for bone graft to be placed on the medial and lateral bone contacting regions of the device.

The Spinal Simplicity Posterior Fusion Plate/HA Posterior Flate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions: · Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Posterior Fusion Plate/HA Posterior Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1). The Spinal Simplicity Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions: • Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1). The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions: • Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1). The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions: · Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1). The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions: - Lumbar spinal stenosis; · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several gripping features for attachment of the device to the spinous processes. The Minuteman devices are available in multiple sizes to accommodate varying patient anatomy. The Minuteman devices are made from Ti6A14V and Ti6A14V ELI. The HA versions of the Minuteman devices have an additional hydroxyapatite coating on the distal regions of the device.

The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: · Lumbar spinal stenosis; · 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); and/or • tumor. The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Minuteman G5 consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include gripping features on the boneinterfacing surfaces of each Plate for attachment to the spinous processes. The Minuteman G5 device is available in multiple sizes to accommodate varying patient anatomy. The Minuteman G5 is made from titanium alloy Ti6A14V ELI and has a hydroxyapatite coating on the distal regions of the device.

The Spinal Simplicity Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: · Lumbar spinal stenosis; · 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); and/or • tumor. The Posterior Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1). The Spinal Simplicity Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: · Lumbar spinal stenosis; · 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); and/or • tumor. The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1). The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: · Lumbar spinal stenosis; · 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); and/or • tumor. The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a mimimally invasive posterior approach (T1-S1). The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, nonpedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: - Lumbar spinal stenosis; - 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); and/or - tumor. The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1).

The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate constructs. The Plate components include several spiked grips at the ends of each Plate for attachment to the spinous processes. The Minuteman devices are available in multiple sizes to accommodate varying patient anatomy. The Minuteman devices are made from Ti6Al4V and Ti6Al4V ELI. The HA versions of the Minuteman devices have an additional hydroxyapatite coating on the distal regions of the device.