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The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.

The VCFix Spinal System is a cannulated screw-shaped implant with an expandable plate structure and is available in multiple sizes to accommodate varying patient anatomy. A pair of implants are inserted into the pedicles and manipulated with the toolset, resulting in the expansion of the device to restore the vertebral height. The implant is made of titanium alloy (Ti6Al4V ELI). During the procedure, the surgeon inserts the implants bilaterally through each pedicle of the fractured vertebra and adjusts the height and angle of the device (to correct local kyphosis) based on the unique vertebral fracture of the patient. The VCFix Spinal System includes sterile, single-use implantation kits and a preparation kit. The kits include a pair of implants and all tools necessary for preparing the implant site and vertebral body expansion. The positioning and expansion of the implant must imperatively be followed by the injection of Teknimed F20 bone cement (K103433) to fixate the restored vertebral body. The bone cement and its delivery system are sold separately.

The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system. Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use. The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.

SPECTRUM® GV Bone Cement is indicated for the fixation of the REMEDY® & REMEDY SPECTRUM® GV Spacers, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total joint arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

The VADER® Pedicle System: The VADER® Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis) and spinal instability due to infection, surgical debridement, or decompression. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery. VADER®one Pedicle System: The VADER ®one Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of: - Polyaxial cannulated, fenestrated pedicle screws, - Polyaxial, cannulated, pedicle screws, ● - Curved. straight. S-rods. J-rods. ● - Connectors . The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

NEO Pedicle Screw System™ The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation 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 (scoliosis, kyphosis), tumor, pseudarthrosis, and/or failed previous fusion. When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels (thoracic and lumbar T1 to L5) where the structural integrity of the spine is not severely compromised. BonOs® Inject BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1) BonOs® Iniect BonOs® Iniect is a radiopaque, iniectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures. 2) NEO Pedicle Screw System™ The NEO Pedicle Screw System™ has been optimized and consists of 27 pedicle and 8 iliac screws, rods and connectors which are available in different sizes. The system includes a reduced optimized trav of instruments providing options for open and MIS surgical techniques. The implants are all delivered sterile and ready to use. The relevant instruments are mainly delivered as single use, disposable and delivered sterile, just a few optional instruments are reusable and delivered non-sterile. All the system components are made of materials compliant with ASTM and/or ISO standards. Screws and rods are made of titanium-alloy (Ti-6AI-4VELI) and comply with ISO 5832-3 or ASTM-F136. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy CoCrMo (ISO 5832-12, ASTM F1537) and delivered sterile, Connectors are made out of titanium alloy and delivered sterile. The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and 10.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 35 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length. The NEO Pedicle Screw System™ provides immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system can be used via an open or minimally invasive posterior approach. lliac screws shall be placed via Sacral Alar Iliac (SAI) and/or Posterior Superior Illiac Spine (PSIS) approach. The size and form of the device is adjusted to the morphology of the body and the surgical technique.

GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities: - o GENTAFIX® 1 is a high viscosity bone cement intended for digital use. - . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application. - GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.

The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments 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 (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; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are 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 thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.

OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.

Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period. Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty fusion, etc.). Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.q., crutches, walkers) throughout the implant period. Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The Hip Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemi-hip spacers in a two-stage septic hip joint endoprosthesis. The Hip Spacer Molds are available as modular system, which is combinable to obtain different sized spacers. The Femoral and Tibial Knee Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary knee spacers in a two-stage septic knee joint endoprosthesis. The Knee Spacer Molds are available as modular system, which is combinable to obtain different sized spacers. The Shoulder Spacer Molds are sterile, sinqle use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemishoulder spacers in a two-stage septic glenohumeral joint endoprosthesis. The Shoulder Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is provided as a twocomponent system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.