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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136. The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only. The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.

The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and id in the repair of bone fractures. The indications for use are as follows: · 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 and older, adults scoliosis and kyphosis; · Spine degenerative surgery as an adjunct to spinal fusions. · Intended for use with a posterior spinal instrumentation construct when ligamentation is needed. The LigaPASS™ system may also be used in conjunction with other medical implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this submission is to expand the indications of the LigaPASS™ system to include the use with a posterior spinal instrumentation construct when ligament augmentation is needed. The LigaPASS™ 2.0 Ligament Augmentation System provides surgeons the ability to mimic anatomical muscle and ligament functionality and stabilization between vertebrae that are collapsed during surgery before fusion. The LigaPASS™ 2.0 Ligament Augmentation System is designed to restore balance and stability as a complement to a posterior thoracolumbar fixation system. Ergonomic instrumentation provides smooth assembly with self-stabilizing tensioners and torque-limiting locking tools. The LigaPASS™ 2.0 Ligament Augmentation System consists of a polyester (PET) band and titanium alloy medial open connector with 2 set screws. LigaPASS™ bands allow the surgeon to create a posterior vertebra anchorage without theuse of a pedicle screw or hook. Instead of a pedicle screw or hook, the LigaPASS™ bands are laced around the vertebra independently of the vertebra anatomy and then connected to a LigaPASSTM connector to make the rod-bone connection. The LigaPASS™ 2.0 bands are comprised of a PET braid and pure titanium (T40) malleable leads at the ends of the bands. The malleable tips help the surgeon to lace the band around the vertebra. They can be bent by the surgeon to make it pass under and through the vertebral body easier. The LigaPASS™ connectors allow surgeons to attach a rod to a vertebral body without the use of the pedicle. Instead of a pedicle screw, the LigaPASS™ connector use a facet band to make the rod-bone connection. The connectors are comprised of a connector body, a rod set screw, a locking set screw for the band and a polyester band. The body of these connectors is manufactured from titanium allov (Ti-6Al-4V). The part is compatible with any rods made of titanium or cobalt chromium alloys between diameters 5.5 mm and 6.0 mm.

The Infinity™ OCT System is intended to provide immobilization 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: - 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, 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 VertexTM 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 and Vertex™ Reconstruction System package insert for a list of the indications of use. Note: The 3.0mm multi axial screw (MAS) reguires 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 offiset connectors and MAS extension connectors are not intended to be used with 3.0mm screws. Note: Segmental fixation is recommended for these constructs. The PASS OCT spinal system is intended to provide immobilization 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: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and 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 PASS OCT spinal system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.

The Infinity™ OCT System and PASS OCT Spinal System (including UNID™ OCT Patient-Specific Rods) are posterior systems, which consist of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537. The purpose of this submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNID™ OCT Patient-Specific Rods. The subject rods are designed and manufactured for one specific patient and are compatible with Infinity™ OCT System and PASS OCT Spinal Systems (cranially) and the CD Horizon Spinal System (caudally). The UNID™ OCT Patient-Specific Rods must be used during surgery for this patient only and must not be reused (single use only).

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), 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 pediativ indications noted. 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™ System is intended to treat pediatic 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. 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™M 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 The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion. Except for rod plates and caps for sacral plates, when non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon Spinal System and PASS LP™ Spinal System (including UNiD™ Patient Specific Rods) consist of a variety of shapes and size of rods, hooks, screws, crosslink, plates, staples and connecting components, as well as implants 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. The purposes of this submission are to: - Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014) - Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods" UNiD™ Patient Specific Rods are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, or in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. UNiD™ Patient Specific Rods are differentiated in two subgroups: UNiD™ Patient Specific Standard Rods (UNiD ROD) and UNiD™ Patient Specific Percutaneous Rods (UNiD™ Patient Specific Rods have been designed and manufactured for one specific patient. UNiD™ Patient Specific Rods must be used during surgery for this patient only and must not be reused (single use only). The UNiD™ Patient Specific Rods 4.75 diameter rods are not compatible with the PASS LP system. For a complete guide to the system, it is important to refer to the surgical technique.

The UNID™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The MEDICREA UNiD Spine Analyzer was developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. This web-based, Software as a Medical Device (SaMD) application aims to simulate a surgical strategy, make measurements on a patient image, and draw patient-specific rods or choose from a pre-selection of standard implants and ordering the patient-specific rods. The UNiD Spine Analyzer allows the user to: - 1) Measure radiological images using generic tools and "specialty" tools - 2) Plan and simulate aspects of surgical procedures The purpose of this submission is to request clearance for the UNiD Spine Analyzer v4.0. The changes introduced are as follows: - . Addition of the Degenerative Predictive Model, which corresponds to a type of adult spinal fusion degenerative construct, trained with a retrospective longitudinal patient dataset. - . Update to the existing Adult Predictive Model consisting of three predictive model modules trained with retrospective longitudinal patient datasets, where one was included in Adult Deformity Model 1 (TKA-12) and two included in Adult Deformity Model 2 (PTA-12 and PTA-34). - Update to the existing Pediatric Predictive Model consisting of two predictive model modules trained with retrospective longitudinal patient datasets (PediaLL and PediaPT), - Addition of the display of a Predicted Value derived from a static machine-learning based model . when the user views simulated quantitative radiographic parameters of a planned surgery, generated when the Degenerative, Adult or Pediatric Predictive Models are used. - . The subject device update also includes the addition of implant templates among a preselected database of Medtronic standard implants cleared in in the following 510(k)s: K073291, K083026, K091813, K110543, K113528, K120368, K150135, K152277, K172199, K172328, and K201267.

The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion. Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediative patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LPTM Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ Spinal System 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), 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 pediativ indications noted. 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™ 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. 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.

The PASS LP" Spinal System is composed of screws, hooks, rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications. CoCr rods and implants are manufactured in Cobalt-Chromium Molybdenum alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. Under no circumstances are the implants reusable. 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. The purpose of this submission following: - introduce new PASS LP™ Spinal System 'Universal Crosslinks' components - expand use of the previously cleared CD Horizon™ Spinal System rods with the subject PASS LP™ Universal Crosslinks - expand use of previously cleared CD Horizon™ Spinal System hooks with previously cleared PASS LP™ Spinal System components

The C-CURVE® Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used C-Curve screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

MEDICREA® INTERNATIONAL S.A. C-CURVE® is composed of a cervical cage range stabilized by C-CURVE® screws. The titanium cage is composed of two pre-assembled components (the cage body and an expansion screw) that enable its expansion and adaptation of its lordotic angle. The cages are delivered individually and the screws are provided separately by two. The cages are available in different footprints and heights. These implants are designed to be inserted between two adjacent cervical vertebrae after removal of the disc. C-CURVE® is implanted by anterior approach. It is important to refer to the surgical technique and to the Instructions For Use (see paragraph «IMPLANT INSERTION», especially to use the two screws to stabilize the cage). C-CURVE® can be considered as a stand-alone cage if the two screws are used to stabilize the cage. If it is not the case, an additional fixation system must be added. Titanium cages & screws are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications. Under no circumstances are the implants reusable.

MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions. The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient. MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001. Function: The UNiD® IB3D ALIF was developed as an implant: - to provide immobilization and stabilization of posterior spinal segments . - to augment the development of a solid spinal fusion ● - . to provide stability to ease fusion - to be mechanically resistant to allow the fusion of the operated level

MEDICREA® INTERNATIONAL IB3D ALIF device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IB3D ALIF Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with bone graff. UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.