This is a list of 50 orthopedic and spine devices that have received FDA 510(k) clearance for the entire system, new system generations or additions to the system in 2011. This list is not an endorsement of any product or company chosen for inclusion.
Accolade II Femoral Hip Stem from Howmedica Osteonics. Howmedica Osteonics received FDA clearance for its novel tapered hip system in March. The system is a tapered non-porous coated femoral stem indicated for use in cementless, press-fit applications. The stem is designed to address variations in patient femoral morphology and length can be reduced to facilitate intraoperative insertion.
Aequalis Ascend Modular Reverse Shoulder System from Tornier. The Aequalis Ascend Modular Reverse Shoulder System received FDA clearance in June after more than 12 years of development. It is indicated for patients with a functional deltoid muscle and significant disability after arthropathy for massive irreparable rotator cuff tears. The system includes the Aequalis Reversed Shoulder G2 Baseplate, glenoid spheres and the lateralized polyethylene insert.
Aleutian Lateral from K2M. The Aleutian Lateral is comprised of anatomically designed interbody implants made of PEEK material and meant for use in conjunction with the company's Ravine Retractor. The implants have the potential to increase visualization of bone graft and aid in accurate fusion assessment. The device received FDA clearance in March.
AlloFuse Plus from AlloSource. AlloFuse Plus combines previous AlloFuse demineralized bone matrix capabilities with the osteoconductive properties of cancellous bone. The device received FDA clearance in January and allows for osteoinductivity and osteoconductivity in the same product. The device is used as an autograft extender and bone void filler in gaps that aren't imperative to the bony structure's stability.
Anatomical Shoulder Combined System from Zimmer. The Anatomical Shoulder Combined System's modularity and design allow for reproducible reconstruction of the glenohumeral joint to restore limb kinematics. During the procedure, the humeral head prosthesis is adjusted to the anatomical position on the humeral stem prosthesis and locked. The Anatomical Shoulder Combined System recently received FDA clearance in March.
Apex ARC Hip Stem from OmniLife Science. The Apex ACR Hip Stem received FDA clearance in June and is designed to allow the surgeons benefits of resurfacing without the disadvantages associated with metal-on-metal articulation. The stem minimizes the amount of bone resection necessary during surgery and allows the surgeon to dissect fewer soft tissues.
Arthrex BioComposite SutureTak from Arthrex. The Arthrex BioComposite Suture Tak is a 2 millimeter biocomposite suture anchor loaded on a driver and intended for use during suture or tissue fixation of the foot, ankle, knee, hand, wrist, shoulder and elbow. The device received FDA clearance in March and is equivalent to previously approved Arthrex anchors.
Ascent Posterior Occipital Thoracic System from Orthofix. Orthofix's Ascent Posterior Occipital Thoracic System received FDA Clearance in May. The system is designed for surgeons taking on complicated fusion cases from the base of the skull to the thoracic region. The system's multi-axial screw includes 66 degrees of angulation and biased angle screws are available to accommodate a range of patient anatomies.
Biomet Sports Medicine Juggerknot Soft Anchor from Biomet. In March, Biomet received FDA clearance for its Juggerknot Soft Anchor, used for soft tissue-to-bone fixation in the shoulder, foot and ankle, elbow, knee, hand and wrist and hip. The device consists of a coreless sleeve suture and suture.
Biomet Sports Medicine Sternal Closure System from Biomet. The Biomet Sports Medicine Sternal Closure System is used in the stabilization and fixation of anterior chest wall fractures following sternotomy and sternal reconstructive surgical procedures. Implants for the application include Clips and ZipLoop constructs. The single-use device received FDA clearance in April.
BioSpine VBR System from Aesculap Implant Systems. Aesculap, a B. Braun Company, received FDA clearance for its BioSpine VBR System in June. The system is an adjustable vertebral body replacement device designed to improve spine stability. The device can be adjusted to the exact length of the patients' anatomy and locks in place at the desired length. The device is intended for use in the thoracolumbar spine for partial or total replacement of the unstable vertebral body.
Consensus Knee System from Consensus Orthopedics. The Consensus Knee System includes an oval patella and anatomical femoral and tibial component. The oval patella is designed to improve contact area flexion. The tibial inserts are designed to increase joint stability and contact area, which reduces wear. The system received FDA clearance in April.
CoRoent Small Interlock System from NuVasive. In February, NuVasive received FDA clearance for the CoRoent Small Interlock System. The system is a standalone anterior cervical interbody device that includes a PEEK implant cage with titanium alloy radiographic markers and washers. The devices are manufactured from PEEK-Optima and are intended for use in patients with degenerative disc disease at one level.
Cougar LS System from Johnson & Johnson's DePuy Orthopaedics. The Cougar LS Cage was launched last October at the North American Spine Society annual meeting and the system received FDA clearance this past May. The cage has a self-distracting tip and bulleted nose for a streamlined insertion.
Cutting Edge Spine Interbody Fusion Device from Cutting Edge Spine. Cutting Edge Spine received FDA clearance for its interbody fusion device in April. The device is intended for use in patients with degenerative disc disease with Grade 1 spondylolisthesis at one or two contiguous levels. It is used with autologous bone graft to facilitate fusion and is implanted during a direct posterior, transforaminal retroperitoneal or anterior approaches.
Ellipse Occipito-Cervico-Thoracic Spinal System from Globus Medical. The Ellipse system received FDA Clearance in May. The system is designed for the swift installation of implants during complex spine cases. The system includes a non-treaded locking cap and the ElliptiClick, a drop, click and lock feature that retains the rod for ease of placement.
Emerald Spinal System from Mazor Robotics. Emerald Spinal System consists of proprietary thoracolumbar implants and accessories guided with unmatched accuracy by Renaissance, Mazor Robotics state-of-the-art guidance system. Emerald provides comprehensive, flexible solutions that allows Intraoperative choice between detachable, interchangeable MonoAxial and PolyAxial Tulips and pedicle screws. Using Emerald allows soft- and hard-tissue sparing, facilitating recovery; it can also reduce intraoperative radiation.
Endofuse Intra-Osseous Fusion System from Wright Medical Technologies. Wright Medical Technologies received FDA clearance for the Endofuse Intra-Osseous Fusion System in May. The system includes titanium alloy rods and beams intended for surgical implantation in the bone for fixation of fractures. The rods and beams have a CP titanium spray coating to help achieve fixation.
Exactech Proliant Polyaxial Pedicle Screw System from Exactech. Exactech Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that includes several sizes of polyaxial screws, rigid rods and cross connectors for immobilization and stabilization of spinal segments in adjunct to fusion. The system includes instrumentation to assist the surgeon during the traditional open procedure. The system received FDA clearance in January.
Flexfusion Fixation Implant from Nextremity Solutions. Nextremity Solutions received FDA clearance for the Flexfusion Fixation Implant in March. The proximal and distal components of the device are provided as a set and the implant is fabricated from medical grade stainless steel. The implant is designed to establish natural angulations of the fused inter-digital joint during inter-digital repair and fusion of the lesser toes.
Gladiator Plasma Classic Hip System from Wright Medical Technology. The Gladiator Plasma Classic Hip Stem is a straight, uncemented stem featuring a rectangular cross-section. The stem has a thick titanium plasma spray coating on the proximal third of the stem surface and is available in standard and extended neck offsets. The device is indicated for use in total hip arthroplasty and received FDA clearance in May.
IFuse Implant System from SI-Bone. The IFuse Implant System is designed for use during treatment of patients with sacroiliac joint problems. The system contains titanium implants and associated surgical instruments for the minimally invasive procedure. The implants are delivered using a cannulated delivery system and soft tissue protection.
InFill Intervertebral Body Fusion Device from Pinnacle Spine. Pinnacle Spine received FDA clearance for its InFill Intervertebral Body Fusion Device in April. The device is a radiolucent implantable manufactured from PEEK and tantalum. The system includes various implant sizes to fit the patient's individual anatomy and condition. It is designed for use with autogenously bone graft.
Integrity Spinal Care System from Integra LifeSciences. Integrity Spinal Care System received FDA clearance in April and is intended for use to manage pain and disability in patients with lower back and neck pain, including anatomical dysfunctions of the spine. The system includes a bed split into two cushions that both slide in the horizontal plane and are only on low friction runners. The sides have the ability to lock independently.
InterContinental Plate-Spacer from Globus Medical. The InterContinental Plate-Spacer is Globus Medical's second generation system in minimally invasive lateral fixation. The plate and spacer are contained within the disc space and the optimized screw design compressively loads the graft to promote fusion. The device received FDA clearance in May.
iTotal Cruciate Retaining Knee Replacement System from ConforMIS. ConforMIS received FDA approval for the iTotal patient-specific implant for total knee replacements in January and announced the first successful surgeries using the device in June. Computer modeling is used to build a three-dimensional image based on the patients' CT Scans, and then the personalized implants and cutting jigs are created.
KneeAlign System from OrthoAlign. The KneeAlign is a small surgical navigational system for tibial alignment during total knee arthroplasty. The system is compatible with TKA implant systems and received FDA clearance in April. The device doesn't require capital expenditures and entails only a short learning curve.
Kyphon Inflation Syringe from Medtronic. Medtronic received FDA clearance for its Kyphon Inflatable Syringe in January. The device is intended for use to inflate and deflate devices, such as inflatable bone tamps, and to measure pressure within the inflatable device intraoperatively. The device is designed to generate and monitor pressure up to 700psi.
Kyphon Xpede Bone Cement from Medtronic. The Kyphon Xpede Bone Cement is a quick-to-dough polymethylmethacylate bone cement that is indicated for use with the Kyphon Balloon Kyphoplasty minimally invasive procedure. The device is used for treatment of spinal fractures and reaches the doughy state twice as quickly as other Kyphon bone material.
Lanx Intervertebral Body/VBR Fusion System. Lanx received FDA clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System in February. The system now includes an additional cervical intervertebral body fusion device implants with increased graft volume, additional larger implant footprints, implants with convex superior endplates and the ability to accommodate a threaded inserter.
LP Cage from Medyssey Spine. The LP Cage is indicated for use with patients who have degenerative disc disease at one or two contiguous levels from L2-S1 for posterior lumbar interbody fusion. Medyssey received FDA clearance for the cage in April, and the company aims for a full commercial release of the product by the fourth quarter of 2011.
Maxfire MarXmen Meniscal Repair Device from Biomet. This device, cleared by the FDA in June, is the next generation for Biomet's all-inside, all-suture meniscal repair technology. The Maxfire MarXmen includes a one-handed trigger delivery system that requires a small amount of insertion force compared to other similar devices and using the rigid tube cannula can help protect the joint intraoperatively.
MIS Anterior Cervical Plating System from Life Spine. Life Spine received FDA clearance for its MIS Anterior Cervical Plating System in June. The system's components include temporary implants intended for anterior fixation of the cervical spine during fusion. The system has a variety of plate and screw sizes as well as associated instruments.
Mountaineer OCT Spinal System from DePuy Spine. Cobalt-Chromium Allo Rods, which received FDA clearance in April, are now available for the Mountaineer Occipito-Cervico-Thoracic Spinal System. These new rods are designed to maintain the sagittal and coronal alignment surgeons demand for deformity correction, without compromising imaging capabilities. The Mountaineer OCT Spinal System is indicated for use during rigid posterior fixation of the OCT spinal region and allows surgeons to anatomically place screws and rods with minimal contouring.
Multifit Total Hip System from Biotech. Biotech received FDA clearance for the Multifit Total Hip System in January. The system includes the option of cementless and cement collared stems and metal femoral heads. The system can be used to replace a defective hip joint in specific instances, such as congenital hip dysplasia.
Revere Sacral Plates from Globus Medical. Globus Medical received FDA clearance to add Revere Sacral Plates to the Revere Stabilization System in March. When used as a posterior pedicle screw system, the system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for patients with acute and chronic instabilities or deformities.
SeaSpine Spacer System from SeaSpine. Sea Spine received FDA clearance for its spacer system in May. The system is intended for use during intervertebral body fusion for patients with degenerative disc disease. The system can be used as a vertebral body replacement device in the thoracolumbar spine to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body. It is intended for use with bone graft.
SImmetry Sacroiliac Joint Fusion System from Zyga Technologies. Zyga Technologies received FDA clearance for SImmetry Sacroiliac Joint Fusion System in January. The system is indicated for patients with degenerative sacroiliac and sacroiliac joint disruptions. The system includes several threaded, cannulated implants and associated instrumentation for the minimally invasive procedure.
Spartek Variable Angle Pedicle Screw Posterior Fusion System from Spartek Medical. The Spartek Variable Angle Pedicle Screw System received FDA clearance in April and is intended for use in the thoracic, lumbar and sacral spine. The single-use device can be used in one or more segment stabilizations to facilitate fusions during spine surgery.
Streamline TL Spinal Fixation System from Pioneer Surgical Technologies. The inclusion of the FixxSure Cross Link to Pioneer Surgical's Streamline TL Spinal System received FDA clearance in May. The system's components are intended for use during non-cervical spinal fixations as an adjunct to fusion. The Cross Link is designed to provide added fixation to the spinal construct.
Stryker Patient Specific Cutting Guide from Stryker. The ShapeMatch Cutting Guides received FDA clearance in May and are indicated for use with Stryker's Triathlon Total Knee System. The patient-specific three-dimensional data derived from MRI or CT scans is used to design the guidelines. The technology employs software to develop customized preoperative surgical plans for each patient.
Symmetric Total Knee Augments from Signal Medical. The Symmetric Total Knee Augmentation is intended to complement the Symmetric Total Knee System and consists of metallic wedges, stems, cones and sleeves for use during total knee arthroplasty. All components are for cemented use. Signal Medical received FDA clearance for the device in March.
Synthes Hemostatic Bone Putty from Synthes USA. Synthes received FDA clearance for its Hemostatic Bone Putty in May. The device is designed to stop bone bleeding by establishing a physical barrier along the edge of damaged bone. The HBP includes synthetic water soluble polymers which form a ready-to-use haemostatic agent, which is substantially eliminated from the defect site within 48 hours.
TranS1 AxiaLIF+ from TranS1. In March, TranS1 received FDA clearance for its AxiaLIF 1L+, the next generation of its original system launched in 2005. The system allows for more precise distraction capabilities and improved pull-out strength. The product is set for full commercial release during the second half of 2011.
Trinity Acetabular System from Corin USA. The Trinity Acetabular System received FDA clearance in March and is intended for use during total hip arthroplasty. It is indicated for use in patients with non-inflammatory degenerative joint disease and is intended for cementless use only.
Trio Trauma Spinal System from Stryker. The Trio Trauma Spinal System from Stryker received FDA clearance in March. The system includes cannulated pedicle screws in a variety of lengths and both straight and pre-bent rods, and components are manufactured from titanium alloy. The system is intended for percutaneous, posterior, non-cervical fixation of the spine with degenerative and traumatic conditions.
Total Shoulder System from Shoulder Innovations. The Total Shoulder System received FDA clearance in January and consists of modular humeral stems and heads and a glenoid component. The humeral stems and heads are manufactured from cobalt chrome and the glenoid component from ultra high molecular weight polyethylene.
Vault ALIF System from Spinal USA. Spinal USA received FDA clearance for its Vault ALIF System in April. The system is designed for use with autograft to facilitate fusion of either one or two contiguous levels in the lumbar spine. The standalone system can be used for treatment of patients with degenerative disc disease and Grade 1 spondylolisthesis.
Zenith Pedicle System from Apollo Spine. In March, Apollo Spine received FDA clearance for its Zenith Pedicle System. The system is intended to provide immobilization and stabilization during thoracic, lumbar and sacral spine surgery. The temporary implant system is intended for removal after solid fusion and should only be used with components from the Zenith system.
Zimmer Periarticular Locking Plate System from Zimmer. The periarticular plates in this system were developed using digital laser one-scanning technology to design a device that closely mimicked the shape of the bone. The plates have decrease thickness toward the joint line which reduces soft tissue irritation. The system was developed for use during minimally invasive surgical procedures.
Related Articles on Orthopedic Devices:
29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June
20 of the Most Profitable Orthopedic and Spine Device Companies
7 Critical Orthopedic and Spine Device Industry Trends
Aequalis Ascend Modular Reverse Shoulder System from Tornier. The Aequalis Ascend Modular Reverse Shoulder System received FDA clearance in June after more than 12 years of development. It is indicated for patients with a functional deltoid muscle and significant disability after arthropathy for massive irreparable rotator cuff tears. The system includes the Aequalis Reversed Shoulder G2 Baseplate, glenoid spheres and the lateralized polyethylene insert.
Aleutian Lateral from K2M. The Aleutian Lateral is comprised of anatomically designed interbody implants made of PEEK material and meant for use in conjunction with the company's Ravine Retractor. The implants have the potential to increase visualization of bone graft and aid in accurate fusion assessment. The device received FDA clearance in March.
AlloFuse Plus from AlloSource. AlloFuse Plus combines previous AlloFuse demineralized bone matrix capabilities with the osteoconductive properties of cancellous bone. The device received FDA clearance in January and allows for osteoinductivity and osteoconductivity in the same product. The device is used as an autograft extender and bone void filler in gaps that aren't imperative to the bony structure's stability.
Anatomical Shoulder Combined System from Zimmer. The Anatomical Shoulder Combined System's modularity and design allow for reproducible reconstruction of the glenohumeral joint to restore limb kinematics. During the procedure, the humeral head prosthesis is adjusted to the anatomical position on the humeral stem prosthesis and locked. The Anatomical Shoulder Combined System recently received FDA clearance in March.
Apex ARC Hip Stem from OmniLife Science. The Apex ACR Hip Stem received FDA clearance in June and is designed to allow the surgeons benefits of resurfacing without the disadvantages associated with metal-on-metal articulation. The stem minimizes the amount of bone resection necessary during surgery and allows the surgeon to dissect fewer soft tissues.
Arthrex BioComposite SutureTak from Arthrex. The Arthrex BioComposite Suture Tak is a 2 millimeter biocomposite suture anchor loaded on a driver and intended for use during suture or tissue fixation of the foot, ankle, knee, hand, wrist, shoulder and elbow. The device received FDA clearance in March and is equivalent to previously approved Arthrex anchors.
Ascent Posterior Occipital Thoracic System from Orthofix. Orthofix's Ascent Posterior Occipital Thoracic System received FDA Clearance in May. The system is designed for surgeons taking on complicated fusion cases from the base of the skull to the thoracic region. The system's multi-axial screw includes 66 degrees of angulation and biased angle screws are available to accommodate a range of patient anatomies.
Biomet Sports Medicine Juggerknot Soft Anchor from Biomet. In March, Biomet received FDA clearance for its Juggerknot Soft Anchor, used for soft tissue-to-bone fixation in the shoulder, foot and ankle, elbow, knee, hand and wrist and hip. The device consists of a coreless sleeve suture and suture.
Biomet Sports Medicine Sternal Closure System from Biomet. The Biomet Sports Medicine Sternal Closure System is used in the stabilization and fixation of anterior chest wall fractures following sternotomy and sternal reconstructive surgical procedures. Implants for the application include Clips and ZipLoop constructs. The single-use device received FDA clearance in April.
BioSpine VBR System from Aesculap Implant Systems. Aesculap, a B. Braun Company, received FDA clearance for its BioSpine VBR System in June. The system is an adjustable vertebral body replacement device designed to improve spine stability. The device can be adjusted to the exact length of the patients' anatomy and locks in place at the desired length. The device is intended for use in the thoracolumbar spine for partial or total replacement of the unstable vertebral body.
Consensus Knee System from Consensus Orthopedics. The Consensus Knee System includes an oval patella and anatomical femoral and tibial component. The oval patella is designed to improve contact area flexion. The tibial inserts are designed to increase joint stability and contact area, which reduces wear. The system received FDA clearance in April.
CoRoent Small Interlock System from NuVasive. In February, NuVasive received FDA clearance for the CoRoent Small Interlock System. The system is a standalone anterior cervical interbody device that includes a PEEK implant cage with titanium alloy radiographic markers and washers. The devices are manufactured from PEEK-Optima and are intended for use in patients with degenerative disc disease at one level.
Cougar LS System from Johnson & Johnson's DePuy Orthopaedics. The Cougar LS Cage was launched last October at the North American Spine Society annual meeting and the system received FDA clearance this past May. The cage has a self-distracting tip and bulleted nose for a streamlined insertion.
Cutting Edge Spine Interbody Fusion Device from Cutting Edge Spine. Cutting Edge Spine received FDA clearance for its interbody fusion device in April. The device is intended for use in patients with degenerative disc disease with Grade 1 spondylolisthesis at one or two contiguous levels. It is used with autologous bone graft to facilitate fusion and is implanted during a direct posterior, transforaminal retroperitoneal or anterior approaches.
Ellipse Occipito-Cervico-Thoracic Spinal System from Globus Medical. The Ellipse system received FDA Clearance in May. The system is designed for the swift installation of implants during complex spine cases. The system includes a non-treaded locking cap and the ElliptiClick, a drop, click and lock feature that retains the rod for ease of placement.
Emerald Spinal System from Mazor Robotics. Emerald Spinal System consists of proprietary thoracolumbar implants and accessories guided with unmatched accuracy by Renaissance, Mazor Robotics state-of-the-art guidance system. Emerald provides comprehensive, flexible solutions that allows Intraoperative choice between detachable, interchangeable MonoAxial and PolyAxial Tulips and pedicle screws. Using Emerald allows soft- and hard-tissue sparing, facilitating recovery; it can also reduce intraoperative radiation.
Endofuse Intra-Osseous Fusion System from Wright Medical Technologies. Wright Medical Technologies received FDA clearance for the Endofuse Intra-Osseous Fusion System in May. The system includes titanium alloy rods and beams intended for surgical implantation in the bone for fixation of fractures. The rods and beams have a CP titanium spray coating to help achieve fixation.
Exactech Proliant Polyaxial Pedicle Screw System from Exactech. Exactech Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that includes several sizes of polyaxial screws, rigid rods and cross connectors for immobilization and stabilization of spinal segments in adjunct to fusion. The system includes instrumentation to assist the surgeon during the traditional open procedure. The system received FDA clearance in January.
Flexfusion Fixation Implant from Nextremity Solutions. Nextremity Solutions received FDA clearance for the Flexfusion Fixation Implant in March. The proximal and distal components of the device are provided as a set and the implant is fabricated from medical grade stainless steel. The implant is designed to establish natural angulations of the fused inter-digital joint during inter-digital repair and fusion of the lesser toes.
Gladiator Plasma Classic Hip System from Wright Medical Technology. The Gladiator Plasma Classic Hip Stem is a straight, uncemented stem featuring a rectangular cross-section. The stem has a thick titanium plasma spray coating on the proximal third of the stem surface and is available in standard and extended neck offsets. The device is indicated for use in total hip arthroplasty and received FDA clearance in May.
IFuse Implant System from SI-Bone. The IFuse Implant System is designed for use during treatment of patients with sacroiliac joint problems. The system contains titanium implants and associated surgical instruments for the minimally invasive procedure. The implants are delivered using a cannulated delivery system and soft tissue protection.
InFill Intervertebral Body Fusion Device from Pinnacle Spine. Pinnacle Spine received FDA clearance for its InFill Intervertebral Body Fusion Device in April. The device is a radiolucent implantable manufactured from PEEK and tantalum. The system includes various implant sizes to fit the patient's individual anatomy and condition. It is designed for use with autogenously bone graft.
Integrity Spinal Care System from Integra LifeSciences. Integrity Spinal Care System received FDA clearance in April and is intended for use to manage pain and disability in patients with lower back and neck pain, including anatomical dysfunctions of the spine. The system includes a bed split into two cushions that both slide in the horizontal plane and are only on low friction runners. The sides have the ability to lock independently.
InterContinental Plate-Spacer from Globus Medical. The InterContinental Plate-Spacer is Globus Medical's second generation system in minimally invasive lateral fixation. The plate and spacer are contained within the disc space and the optimized screw design compressively loads the graft to promote fusion. The device received FDA clearance in May.
iTotal Cruciate Retaining Knee Replacement System from ConforMIS. ConforMIS received FDA approval for the iTotal patient-specific implant for total knee replacements in January and announced the first successful surgeries using the device in June. Computer modeling is used to build a three-dimensional image based on the patients' CT Scans, and then the personalized implants and cutting jigs are created.
KneeAlign System from OrthoAlign. The KneeAlign is a small surgical navigational system for tibial alignment during total knee arthroplasty. The system is compatible with TKA implant systems and received FDA clearance in April. The device doesn't require capital expenditures and entails only a short learning curve.
Kyphon Inflation Syringe from Medtronic. Medtronic received FDA clearance for its Kyphon Inflatable Syringe in January. The device is intended for use to inflate and deflate devices, such as inflatable bone tamps, and to measure pressure within the inflatable device intraoperatively. The device is designed to generate and monitor pressure up to 700psi.
Kyphon Xpede Bone Cement from Medtronic. The Kyphon Xpede Bone Cement is a quick-to-dough polymethylmethacylate bone cement that is indicated for use with the Kyphon Balloon Kyphoplasty minimally invasive procedure. The device is used for treatment of spinal fractures and reaches the doughy state twice as quickly as other Kyphon bone material.
Lanx Intervertebral Body/VBR Fusion System. Lanx received FDA clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System in February. The system now includes an additional cervical intervertebral body fusion device implants with increased graft volume, additional larger implant footprints, implants with convex superior endplates and the ability to accommodate a threaded inserter.
LP Cage from Medyssey Spine. The LP Cage is indicated for use with patients who have degenerative disc disease at one or two contiguous levels from L2-S1 for posterior lumbar interbody fusion. Medyssey received FDA clearance for the cage in April, and the company aims for a full commercial release of the product by the fourth quarter of 2011.
Maxfire MarXmen Meniscal Repair Device from Biomet. This device, cleared by the FDA in June, is the next generation for Biomet's all-inside, all-suture meniscal repair technology. The Maxfire MarXmen includes a one-handed trigger delivery system that requires a small amount of insertion force compared to other similar devices and using the rigid tube cannula can help protect the joint intraoperatively.
MIS Anterior Cervical Plating System from Life Spine. Life Spine received FDA clearance for its MIS Anterior Cervical Plating System in June. The system's components include temporary implants intended for anterior fixation of the cervical spine during fusion. The system has a variety of plate and screw sizes as well as associated instruments.
Mountaineer OCT Spinal System from DePuy Spine. Cobalt-Chromium Allo Rods, which received FDA clearance in April, are now available for the Mountaineer Occipito-Cervico-Thoracic Spinal System. These new rods are designed to maintain the sagittal and coronal alignment surgeons demand for deformity correction, without compromising imaging capabilities. The Mountaineer OCT Spinal System is indicated for use during rigid posterior fixation of the OCT spinal region and allows surgeons to anatomically place screws and rods with minimal contouring.
Multifit Total Hip System from Biotech. Biotech received FDA clearance for the Multifit Total Hip System in January. The system includes the option of cementless and cement collared stems and metal femoral heads. The system can be used to replace a defective hip joint in specific instances, such as congenital hip dysplasia.
Revere Sacral Plates from Globus Medical. Globus Medical received FDA clearance to add Revere Sacral Plates to the Revere Stabilization System in March. When used as a posterior pedicle screw system, the system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for patients with acute and chronic instabilities or deformities.
SeaSpine Spacer System from SeaSpine. Sea Spine received FDA clearance for its spacer system in May. The system is intended for use during intervertebral body fusion for patients with degenerative disc disease. The system can be used as a vertebral body replacement device in the thoracolumbar spine to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body. It is intended for use with bone graft.
SImmetry Sacroiliac Joint Fusion System from Zyga Technologies. Zyga Technologies received FDA clearance for SImmetry Sacroiliac Joint Fusion System in January. The system is indicated for patients with degenerative sacroiliac and sacroiliac joint disruptions. The system includes several threaded, cannulated implants and associated instrumentation for the minimally invasive procedure.
Spartek Variable Angle Pedicle Screw Posterior Fusion System from Spartek Medical. The Spartek Variable Angle Pedicle Screw System received FDA clearance in April and is intended for use in the thoracic, lumbar and sacral spine. The single-use device can be used in one or more segment stabilizations to facilitate fusions during spine surgery.
Streamline TL Spinal Fixation System from Pioneer Surgical Technologies. The inclusion of the FixxSure Cross Link to Pioneer Surgical's Streamline TL Spinal System received FDA clearance in May. The system's components are intended for use during non-cervical spinal fixations as an adjunct to fusion. The Cross Link is designed to provide added fixation to the spinal construct.
Stryker Patient Specific Cutting Guide from Stryker. The ShapeMatch Cutting Guides received FDA clearance in May and are indicated for use with Stryker's Triathlon Total Knee System. The patient-specific three-dimensional data derived from MRI or CT scans is used to design the guidelines. The technology employs software to develop customized preoperative surgical plans for each patient.
Symmetric Total Knee Augments from Signal Medical. The Symmetric Total Knee Augmentation is intended to complement the Symmetric Total Knee System and consists of metallic wedges, stems, cones and sleeves for use during total knee arthroplasty. All components are for cemented use. Signal Medical received FDA clearance for the device in March.
Synthes Hemostatic Bone Putty from Synthes USA. Synthes received FDA clearance for its Hemostatic Bone Putty in May. The device is designed to stop bone bleeding by establishing a physical barrier along the edge of damaged bone. The HBP includes synthetic water soluble polymers which form a ready-to-use haemostatic agent, which is substantially eliminated from the defect site within 48 hours.
TranS1 AxiaLIF+ from TranS1. In March, TranS1 received FDA clearance for its AxiaLIF 1L+, the next generation of its original system launched in 2005. The system allows for more precise distraction capabilities and improved pull-out strength. The product is set for full commercial release during the second half of 2011.
Trinity Acetabular System from Corin USA. The Trinity Acetabular System received FDA clearance in March and is intended for use during total hip arthroplasty. It is indicated for use in patients with non-inflammatory degenerative joint disease and is intended for cementless use only.
Trio Trauma Spinal System from Stryker. The Trio Trauma Spinal System from Stryker received FDA clearance in March. The system includes cannulated pedicle screws in a variety of lengths and both straight and pre-bent rods, and components are manufactured from titanium alloy. The system is intended for percutaneous, posterior, non-cervical fixation of the spine with degenerative and traumatic conditions.
Total Shoulder System from Shoulder Innovations. The Total Shoulder System received FDA clearance in January and consists of modular humeral stems and heads and a glenoid component. The humeral stems and heads are manufactured from cobalt chrome and the glenoid component from ultra high molecular weight polyethylene.
Vault ALIF System from Spinal USA. Spinal USA received FDA clearance for its Vault ALIF System in April. The system is designed for use with autograft to facilitate fusion of either one or two contiguous levels in the lumbar spine. The standalone system can be used for treatment of patients with degenerative disc disease and Grade 1 spondylolisthesis.
Zenith Pedicle System from Apollo Spine. In March, Apollo Spine received FDA clearance for its Zenith Pedicle System. The system is intended to provide immobilization and stabilization during thoracic, lumbar and sacral spine surgery. The temporary implant system is intended for removal after solid fusion and should only be used with components from the Zenith system.
Zimmer Periarticular Locking Plate System from Zimmer. The periarticular plates in this system were developed using digital laser one-scanning technology to design a device that closely mimicked the shape of the bone. The plates have decrease thickness toward the joint line which reduces soft tissue irritation. The system was developed for use during minimally invasive surgical procedures.
Related Articles on Orthopedic Devices:
29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June
20 of the Most Profitable Orthopedic and Spine Device Companies
7 Critical Orthopedic and Spine Device Industry Trends