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Grafton™ DBM and Grafton Plus ™ DBM Paste are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space (excluding Flex or Crunch), pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. When used in intervertebral body fusion procedures, Graft™ DBM (excluding Flex or Crunch) and Grafton Plus ™ DBM Paste must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Grafton™ DBM and Grafton Plus™ DBM Paste are absorbed/remodeled and replaced by host bone during the healing process. Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, pelvis and extremities) not intrinsic to the stability of the bony structure. Voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile water in order to adjust consistency and handling of bone graft material. When used in intervertebral body fusion procedures, Magnifuse™ Bone Graft must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Magnifuse™ Bone Graft is resorbed/remodeled and is replaced by host bone during the healing process.

The Grafton™ DBM, Grafton Plus™ DBM Paste, and Magnifuse™ Bone Graft devices in this submission are human bone products containing human demineralized bone matrix (DBM). Grafton™ DBM is a human bone product that contains human DBM with an inert additive. Grafton™ DBM is produced in particular physical forms (Grafton™ DBM Gel, Grafton™ DBM Putty, Grafton™ DBM Matrix, Grafton™ DBM Orthoblend) and/or handling property. Grafton™ DBM is provided in ready-to-use form and is intended in single patient, single use containers. Grafton™ DBM is identical to the device cleared in K051195. Grafton Plus™ DBM Paste is human demineralized bone matrix combined with an inert additive to yield a product having a particular physical form and/or handling property. Grafton Plus™ DBM Paste is identical to the device cleared in K043048. Magnifuse™ Bone Graft is a human bone allograft product containing human DBM and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps or the skeletal system not intrinsic to the stability of the bony structure. Magnifuse™ Bone Graft is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use. Magnifuse™ Bone Graft is identical to the device cleared in K082615.

Mastergraft™ Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Matrix EXT must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mastergraft™ Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Strip must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mastergraft™ Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps not intrinsic to the stability of the bony structure. Additionally, Mastergraft™ Putty can be used with autograft as a bone graft extender. Mastergraft™ Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Mastergraft™ Putty resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mastergraft™ Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, Mastergraff™ Granules can be used with autograft as a bone graft extender. Mastergraft™ Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. Mastergraft™ Granules provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

The Mastergraft™ Family of bone grafts in this submission includes Mastergraff™ Matrix EXT, Mastergraft™ Strip, Mastergraft™ Putty, and Mastergraft™ Granules. The devices all include osteoconductive biphasic calcium phosphate ceramic granules in different biocompatible physical forms supplied sterile for single patient use. Mastergraft™ Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation. Mastergraft™ Matrix EXT is supplied sterile in a premixed strip form for single patient use. Mastergrafi™ Matrix EXT is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate. Mastergraft™ Matrix EXT is identical to the device cleared in K141824. Mastergraff™ Strip is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the Mastergraft™ Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. Mastergraft™ Strip is supplied sterile in a premixed strip form for single patient use. Mastergrafi™ Strip is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects. Mastergraft™ Strip is identical to the device cleared in K082166. Mastergraff™ Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the Mastergraft™ Putty device is Type I bovine collagen. The biphasic ceramic portion of Mastergraft™ Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. Mastergraft™ Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. Mastergraft™ Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. Mastergraft™ Putty is biocompatible. Mastergraft™ Putty readily absorbs bone marrow aspirate and was shown to heal bone defects. Mastergraff™ Putty is identical to the device cleared in K071813. Mastergraft™ Granules is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MASTERGRAFT® Granules is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Granules is an osteoconductive porous implant. Mastergraft™ Granules is identical to the device cleared in K082918.

MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use. The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate.

The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are in the temporary stabilization of the anterior spine during the development of spinal first with: 1) degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by paiient history and radios), 2) trauma (including fractures). 3) tunors, 4) defined as kyphosis, lordosis, or scoliosis). 5) pseudoarthrosis, and/or 6) failed previous fusions. "The DIVERGENCE™ anterior cervical cage component is intended to be used for amerior cervical interbody fusion procedures in skeletally mature patients with cervical dise disease at one level from the C2-C3 disc . Cervical disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symplomatic nerve root and/or spinal confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-overative treatment. The DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with antogenous bone graft and/or allogenic bone graft comprised of cancellous bone grafi and is to be implanted via an open, anterior approach. When used together, the DIVERGENCE™M components can be used only to treat cervical dise disease.

The DIVERGENCE™ Anterior Cervical Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and fusion devices (interbody cages) intended to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The DIVERGENCE™ anterior cervical plates and bone screws are available in broad range of size offerings that are intended for anterior screw fixation intended for stabilization use during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made from titanium allov and are provided sterile. The DIVERGENCE™ anterior cervical cages available in various widths and heights can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants must be used with supplemental fixation. The device is made from medical grade polyetheretherketone (PEEK OPTIMA™), contains titanium alloy wire markers and is provided sterile.

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 (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; 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 disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK 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, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) 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 disc 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. The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically, modified Side Loading/Closed Domino Connectors.

The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc 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. 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 six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft. The purpose of this 510(k) submission includes additional implant sizes and trials for the CLYDESDALE® Spinal System. The subject implants will be offered in 18mm, 22mm, 26mm widths, 0°, 8°, 12°, 18° of lordosis and 8mm, 10mm, 12mm, 16mm. 18mm. 20mm heights, and in the same lengths as the predicate CLYDESDALE® Spinal System, K100175 (S.E. 06/02/2010).

The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc 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. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has : been cleared by the FDA for use in the lumbar spine.

The subject CRESCENT® Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold bone graft material. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 15mm in height and 36mm in length. The devices are manufactured from medical grade PEEK-Optima LTI (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc 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. 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 six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is offered in sterile (PEEK) or non-sterile (PEEK and Titanium Alloy) forms. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum-4 Vanadium EL.I) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone graft.

The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE II™ Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended to be used with allograft and/or autograft. The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T)-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.

The T2 XVBR™ Spinal System is a distractible system. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a standalone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization. The T2 XVBR™ expandable centerpiece is made of titanium alloy. cobalt chrome, and nitinol. The T2 XVBR™ Titanium Alloy end caps are attached to the T2 XVBR™ expandable centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The T2 XVBR™ Spinal System is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system. This device is inserted between two vertebral bodies in the thoracic and lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. The device is not intended to be used as a stand-alone implant. The T2 ALTITUDE™ Expandable Corpectomy System is made of titanium alloy, cobalt chrome, and nitinol. The optional T2 ALTITUDE™ angled end caps may be attached to the T2 ALTITUDE™ expanding centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The T2 ALTITUDE™ Expandable Corpectomy System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.