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KYPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

KYPHON® HV-R® Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degeneralive discase (defined as back pain of discogenic origin with degencration of the disc confirmed by history and radios); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis and/or lordosis); turnor, pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative discase, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforcementioned 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 serew lixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scollosis, Additionally, the CD HORIZON® Spinal System is intended to treat patients diagnosed with the following conditions: spondylolistlesss / spondylolysis and fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or all. Pediatric pedicle screw lixation is limited to a posterior approach. The CD HORIZON® SPIREIM Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T)-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: degenerative disease (as previously defined); spondylolisthesis; trauma; and/or tumor. In order to achieve additional levels of fixation, the 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. Similarly 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. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromiummolybdenum 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, 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. Please 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 that 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. The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt-chromiummolybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium alloy, and cobaltchromium-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 stainless steel, titanium, or cobalt-chromiummolybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients. The purpose of this 510(k) is to add additional sterile rods to the CD HORIZON® Spinal System. The subject rods, along with other components such as metal screws, hooks and other connecting components, are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine. The subject rods are manufactured out of Commercially Pure (CP) Titanium.

The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from PEEK™ OPTIMA™ and is to be used with autogenous bone graft. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM consists hemicylindrical of cages of various widths, heights and depths. The hollow geometry of the implants allows them to be inserted between two cervical vertebral bodies packed with autogenous bone graft in cervical fusion procedures. The ANATOMIC PEEK™ device is to be used with cleared cervical supplemental fixation.

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion. When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System Implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The TSRH® Spinal System is intended to help provide immobilization and stabilization of solnal segments as an adjunct to fusion of the thoracic. Iumbar. and/or sacral spine. The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates 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 tallor-made for the individual case. A subset of TSRH® 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, hooks, screws, CROSSLINK® Plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy and medical grade cobalt -chromium-molybdenum alloy. TSRH® Spinal System staples are specifically excluded for use in pediatric patients. Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and Vantage™ Anterior Fixation System screws. The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well. The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.