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The F3D Lateral Lumbar Interbody System is indicated 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-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 I spondylolisthesis or retrolisthesis at the involved level(s). F3D Lateral Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the Oro Lateral plate for fixation. If using the 1-hole CoreLink Oro Lateral Plate System, additional supplemental fixation is required (e.g. posterior fixation). The CL5 Lumbar Cage is indicated 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-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 I spondylolisthesis or retrolisthesis at the involved level(s). CL5 Lumbar implants are to be used with autogenous 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 CoreLink Oro Lateral Plate System (LPS), in two and four-hole configurations, is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink Oro Lateral Plate System is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. Alternatively, the CoreLink Oro Lateral Plate System may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink Oro LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The CoreLink Oro LPS, one-hole configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The one-hole plate is not intended for use in load-bearing applications. Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the CoreLink Oro Lateral Plate System (LPS) for fixation.

The F3D Lateral Lumbar Interbody System, additively manufactured Ti-6A1-4V ELI per ASTM F3001 implants, and the CL5 Lateral Lumbar Interbody System, PEEK implants per ASTM F2026 with Tantalum per ASTM F560, are lumbar interbody spacers designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lateral lumbar spacers with hollow footprints for placement of graft material feature a wide variety of footprint, height, and lordosis options to accommodate patient anatomical needs. The F3D spacers are designed with a porous surface to optimize bone in-growth. The CL5 spacers are designed with ridges on the superior and inferior surfaces to improve grip against the end-plates and prevent expulsion. The Oro Lateral Plate System consists of plates and screws intended for use as a laterally placed supplemental fixation device via the lateral or anterior lateral surgical approach above the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Oro Plate System implants are manufactured from Ti-6AI-4V ELI per ASTM F136 with Nitinol springs per ASTM F2063 in the plate's screw anti-backout plates. The plates are offered in 1-Screw, or 4-Screw configurations and in multiple lengths for single level fixation. The 1-Screw plate configuration is designed to maintain the relative position of interbody spacers during spinal fusion and is non-load bearing. The 2-Screw and 4-Screw plate configurations are designed as supplemental fixation for lumbar fusion. The plate screws are available in a variety of size options. All Oro plates may be permanently attached to the F3D or CL5 spacers and assume the indications for use of the spacers. The spacer and plate systems have been previously cleared (K183239, K150847, and K190016). This 510(K) submission offers additional implants to the previously cleared sets.

CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

CoreLink Robotic Navigation Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of CoreLink Pedicle Screw System implants (NextGen Pedicle Screw System, CoreLink Midline Fixation System (CentraFix), and Tiger Spine System). The instruments are manufactured from stainless steel.

CoreLink Navigation Instruments is indicated for use during the preparation and placement of Siber Ti Sacroiliac Joint Fusion System implants and Entasis Dual-Lead Sacroiliac Implant System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation S8 System (V1.2.0), 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 of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.

The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation. The F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). When used in the cervical spine (C2-T1), F3D Corpectomy devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are 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, with bone graft used at the surgeon's discretion. When used in the thoracolumbar spine (T1-L5). F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation. The F3D Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation. The F3D™ Lateral System is indicated 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-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 I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous 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 CoreLink® M3™ Stand-Alone ALIF System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation. Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g. posterior fixation) that are cleared for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, or none of the provided screws, then the additional supplemental fixation in the lumbar spine must be used to augment fixation. Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as disco genic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Foundation 3D lumbar implants are indicated 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-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 I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage. The Foundation™ 3D Interbody Cervical Cage 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Foundation™ 3D Interbody Lumbar Cage is indicated 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-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 I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous 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 CoreLink, F3D Interbody System is a collection of additively manufactured, machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical and lumbar spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti- 6A1-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft. The F3D Interbody System has open macroscopic 3D pores with a microscopic, roughened surface and nano scale features.

CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.

The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacrollitis and sacroiliac joint disruptions, to augment immobilization of the sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, nonacute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The Entasis 3D Dual-Lead Sacroiliac Implant System consists of additive and machined dual-lead sacroiliac screws and optional washers to aid in load bearing and conformity to patient anatomy. The Entasis 3D Dual-Lead Sacroiliac Implant System is manufactured from additive titanium alloy (Ti-6Al-4V) per ASTM F3001 or machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. These screws are available in lengths from 30 mm to 110 mm and diameters of Ø7 mm to Ø14.5 mm.

The CoreLink NextGen 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/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The NextGen Pedicle Screw System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of traditional pedicle screw assemblies or modular tulip heads with modular screw shanks with extended tab reduction tulip or closed head tulip options, cross-link connectors, set screws, and spinal rods. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. Implants in the NextGen Pedicle Screw System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.

CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with more CoreLink pedicle screws.

The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively manufactured and machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti-6A-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.20), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.