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Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS 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, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA 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, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, and rods. The system is supported by a comprehensive set of instruments to install the implants within the system for percutaneous and minimally invasive access. All implant components are manufactured from the materials listed in the table below.

Materials: Ti-6Al-4V ELI (ASTM F136), CP Titanium Grade 4 (ASTM F67), CoCrMo Alloy (ASTM F1537), Elgiloy CoCrNi Alloy (ASTM F1058), Nitinol #1 (ASTM F2063)

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The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. These devices are to be used with autograft and/or allograft.

• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System, and PASS OCT Spinal System package inserts for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Stealth™ Spine Clamps

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.

Infinity™ OCT System

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together. Never use titanium alloy and/or cobalt chromium with stainless steel in the same construct. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

To achieve best results, do not use any of the Infinity™ OCT System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, Infinity™ OCT System components should never be reused under any circumstances.

Medtronic Navigated Referencing Devices

Medtronic navigated referencing devices provide rigid fixation to patient anatomy and enables the assembly of a patient reference frame. Various types of instruments are available including spine referencing clamps and associated connections to maintain compatibility with current spine reference frames.

Medtronic navigated referencing devices are compatible with various Medtronic spinal implant systems including Medtronic computer assisted surgery systems, including, but not not limited to, StealthStation™ and/or Mazor™ systems, and Medtronic navigation reusable instruments. These instruments are also compatible with Medtronic's IPC™ Powerease™ System when connected to the Powerease™ Driver.

Medtronic navigated referencing devices are supplied as non-sterile reusable instruments. All devices should be cleaned and sterilized before use.

Medtronic navigated referencing devices are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in accessories. Accessories include cases, trays, lids, caddies, and modules fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic and neurological reusable instruments.

Medtronic Reusable Instruments and Accessories

Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/ Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a legally marketed, validated, and FDA-cleared sterilization wrap to allow steam sterilization of non-sterile devices.

Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

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Curiteva Porous PEEK Cervical Interbody System
The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended to be used with supplemental fixation. The Curiteva Porous PEEK Cervical Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Curiteva Porous PEEK Lumbar Interbody System
The Curiteva Porous PEEK Lumbar lnterbody Fusion System is 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 back pain of discogenic origin 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). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.

Curiteva Porous PEEK Laminoplasty System
The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Curiteva Porous PEEK Standalone ALIF System
The Curiteva Porous PEEK Standalone ALIF devices are 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. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Curiteva Porous PEEK ALIF System (Without Integrated Fixation)
The Curiteva Porous PEEK ALIF devices are intended for use 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 disc 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. The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. 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.

The previously cleared devices consist of a variety of interbody implants and spacers to provide support in the cervical, thoracic, lumbar, and/or lumbosacral regions of the spine. The system implants feature a proprietary nanomaterial surface treatment. This nanoscale surface texture is engineered to produce a uniform nanocrystalline hydroxyapatite layer approximately 10 – 20 nm thick, with individual crystals averaging 91.5 nm in length, and an average width of 10 nm. The surface has demonstrated the ability to reduce contact angle (i.e., increase hydrophilicity) as compared to uncoated and micro-sized HA coated control surfaces and demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications for use.

The CD Horizon™ LigaMAS Head Assembly used with the LigaPASS™ Spinal System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma, used in sublaminar, or facet wiring techniques
• Spinal reconstruction surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis;
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non-pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples, and washers, GDLH™ rods, hooks, connectors, and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws.

Note: certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

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KHEIRON® Spinal Fixation System including patient specific K-ROD 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 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, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric 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.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components and Seaspine Mariner System components that are compatible with Ø5.5 mm and/or Ø6.0 mm rods as well as screws Ø4.5mm or larger and at least 25 mm in length.

Patient specific K-ROD devices are compatible with Seaspine Mariner System components that are compatible with Ø5.5 mm and/or Ø6.0 mm rods as well as screws Ø4.5 mm or larger and at least 25 mm in length.

Patient specific K-ROD devices are compatible with Vital™ Spinal Fixation System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.0mm or larger and at least 20mm in length.

Patient specific K-ROD devices are compatible with Depuy Expedium® and TriALTIS™ Spine Systems components that are compatible with Ø5.5mm and/or Ø6.0 mm rods as well as screws Ø4.35m or larger for Expedium® Spine System and fenestrated screws Ø4.50 mm or larger for TriALTIS™ Spine system.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650, K251804) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is made from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Expedium and TriALTIS Spine Systems are 510(k) cleared pedicle screw systems (K200245 and K231479) that consist of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Expedium and TriALTIS Spine Systems are designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine.

The purpose of this Special 510(k) Device Modification is to extend S.M.A.I.O.'s patient specific K-ROD (K211981, K232650, K251804) for use with the Expedium and TriALTIS Spine Systems (K200245 and K231479).

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KHEIRON® Spinal Fixation System including patient specific K-ROD 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 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, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric 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.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components that are only compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.5mm or larger and at least 25mm in length.

Patient specific K-ROD devices are compatible with Seaspine Mariner System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.5mm or larger and at least 25mm in length.

Patient specific K-ROD devices are compatible with Vital™ Spinal Fixation System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.0mm or larger and at least 20mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650, K251804) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is made from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Vital™ Spinal Fixation System is a 510(k) cleared pedicle screw system (K240539) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Vital™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Vital™ Spinal Fixation System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend S.M.A.I.O.'s patient specific K-ROD (K211981, K232650, K251804) for use with the Vital™ Spinal Fixation System (K240539).

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The Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-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 G6 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 G6 MIS Fusion Plate is a minimally invasive, interspinous-interlaminar fusion device intended for the fixation and fusion of the lumbar and sacral spine. The Minuteman G6 MIS Fusion Plate is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is coated with hydroxyapatite (HA) per ASTM F1185. It is designed for attachment to the posterior non-cervical spine at the spinous processes through its two sets of wings and is intended for use with bone graft material placed within the device. The Minuteman G6 MIS Fusion Plate provides immobilization, stabilization, and fusion across the spinal segments. The core threaded post provides controlled distraction, while a wide range of sizes allows for enhanced anatomical fit. The Minuteman G6 MIS Fusion Plate can easily be placed under fluoroscopy through a lateral transverse MIS approach. The Minuteman G6 MIS Fusion Plate is delivered sterile and individually packed.

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The Universal Spinal System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Universal Spinal System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Universal Spinal System is intended to treat pediatric 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. Pediatric pedicle screw fixation is limited to a posterior approach.

The HOBBIT Growth Connectors are indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis, as part of a growing rod construct.

Universal Spinal System includes the HOBBIT 4.75 Spine System, HOBBIT 5.5/6.0 Spine System, HOBBIT MIS Spine System, HOBBIT 5.5/6.0 HA coated spine system and Anterior Thoracic-lumbar Spine System. Universal Spinal System consists of a variety of structures and sizes of pedicle screws, nut, rods, connectors, hook, transconnectors.

Universal Spinal System is made from Ti-6Al-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472 or Co-Cr-Mo following ASTM F1537.

The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

The implants are intended for single-use only, while the instruments are reusable.

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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates, and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods and Spire™ plates. Screws used in pediatric cases are only cleared for use via a posterior approach. All components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non-pediatric cases. These components include TSRH™ rods, hooks, screws, plates; Crosslink™ plates, connectors, staples, and washers; GDLH™ rods, hooks, and connectors; Crosslink™ bar and connectors and Medtronic multi-axial rods and screws.

Note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt chromium-molybdenum alloy with stainless steel in the same construct.

PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.

To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

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Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

S2AI Screws: The OLYMPIC Posterior Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to OLYMPIC posterior rods the OLYMPIC S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS 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, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

S2AI Screws: The MASADA Modular Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to MASADA posterior rods the MASADA S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA 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, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.

The MASADA Modular Spinal Fixation System S2AI Screw System consist of an assortment of implants in various lengths and diameters, and associated instrument sets for both Open and minimally invasive (MIS) approaches. The S2AI bone screw implant component made from Titanium alloy (Ti-6Al-4V-ELI) as described by ASTM F136. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and provide foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the Iliac trajectories. Additionally, the MASADA S2AI Screw System can be placed into the S1 pedicle. It is designed for connection to the MASADA Pedicle Screw System 5.5mm or 6.0mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods.

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