Here are 50 orthopedic and spine surgery devices that were either launched by device companies or approved by the FDA within the past year. The devices are listed in alphabetical order and were gathered from the FDA 510(k) Clearance list or through additional research. This list is not an endorsement of these devices.
Apex Knee Reconstruction System, OmniLife Science. The Apex Knee System is designed to improve stability and maximize the knee's range of motion. The design was based on extensive clinical anthropomorphic analysis of male and female anatomy. It offers a wide range of primary sizes as well as specifically designed and proportioned intermediates sizes with anatomic characteristics.
*AxiaLIF 2L+ Implant System, TranS1. The AxiaLIF 2L+ is designed to make lumbar fusions around the L4-S1 region of the spine less invasive than other techniques. The new product line is the second generation of the system, first launched in 2008.
Big Foot ALIF, Pioneer Surgical. Pioneer Surgical Technology has launched the Pioneer Advantage portfolio of allograft products, including the anterior lumbar interbody fusion product Bigfoot. The products include machined allografts for cervical and anterior lumbar procedures and de-mineralized strips and cubes for spinal and general orthopedic surgery.
Ceruleau Surgical Probe, NuOrtho. The Ceruleau is designed to leave less damage on the cartilage when performing surgery for injuries or lesions on the knees and shoulders. In most severe injury cases, surgeons using Ceruleau will not need to use screws or plates for the patient.
Ceramic Hip System, Cardo Medical. The Cardo Medical Ceramic Hip System is a metal/ceramic/polymer semi-constrained nonporous un-cemented prosthesis for hip replacement. The system is used with or without bone cement and limits translation and rotation in one or more planes.
CHESAPEAKE Anterior Lumbar Stabilization System, K2M. CHESAPEAKE is an interbody device designed to stabilize the spine through an anterior approach. The system includes the tifix locking technology for screw fixation, in which each screw head forms an autogenic lock to the implant upon insertion.
*COUGAR LS Cage System, DePuy Spine. The COUGAR LS cage has a self-distracting tip and bulleted nose for a streamlined insertion. DePuy Spine also launched VIPER 2, including a versatile rod insertion options for complex and degenerative pathologies, and the PIPELINE LS, including retractor blades where the top of the retractor is radiolucent and allows for the visualization for placement of the COUGAR LS cage.
Construx Mini PEEK VBR System, Orthofix. The Construx System can be used in the thoracolumbar spine for partial vertebrectomy of diseased vertebral body resected for the treatment of tumors, for anrterior decompression of the spinal cord and the restoration of a collapsed vertebral body. It can also treat fractures in the thoracic and lumbar spine.
DuraGen Plus Dural Regeneration Spinal Matrix, Integra LifeSciences. The matrix is an absorbable and sutureless collagen onlay which can be used to repair the dura matter instead of suturing or applying a dural graft. It is used in assisting the repair of fibrous membrane surrounding brain tissue and the spinal cord.
Endoskeleton TO, Titan Spine. The Endoskeleton TO is cleared for use in posterior lumbar interbody fusion. It includes a roughened titanium surface that helps during in the fusion process. The device was designed to promote earlier bone in-growth and stability.
Equinoxe Reverse Shoulder System, Exatech. The system is designed to address scapular notching while maintaining the center of rotation on or close to the face of the glenoid.
EVOLUTION Medial-Pivot Knee System, Wright Medical Group. EVOLUTION is the next generation in Wright's medial-pivot knees, which feature more sizing options and a posterior stabilized option. The system's 'ball-in-socket mechanism' on the medial side is designed to promote stability and range of motion.
EXPEDIUM Spine System, DePuy Spine. The EXPEDIUM system includes longitudinal rods, screws, hooks, transverse and dual-rod connectors, sacral extenders and washers. The new offset system features polyaxial and fixed bolts, angulating and slotted connectors and single and multi-level plating options.
Firebird Pedicle Screw System, Orthofix. The new system is designed for treatment of patients with spinal conditions, including scoliosis and kyphosis. The system's new Direct Vertebral Rotation device provides surgeons with the option to combine rod reduction and direct vertebral rotation in one low profile instrument. The device is designed for quick intraoperative assembly and disassembly.
iDuo Knee Resurfacing System, ConforMIS. ConforMIS released the iDuo G2 patient-specific bicompartmental knee resurfacing system. The iDuo G2 was designed to provide a less-invasive alternative to total knee replacement for patients with diseases in the medial or lateral compartment or the patellofemoral joint.
Interface Acetabular System Hip Implant, Omni Life Science. The InterFace Cup System uses a locking taper design to deliver liner retention with congruency. It can be used for primary or revision total hip replacement and is intended for un-cemented fixation and single-use implantation.
Juliet OL Intervertebral Fusion Device, Spineart. This device is an implantable single or multiple component spinal device intended for intervertebral body fusion in patients with degenerative disc disease at one or two contiguous levels from L2-S1.
*KYPHON Express Curette, Medtronic. The KYPHON Express curette is available in T-tip with a torque resetting device. The device is designed to maximize control when scoring or scraping the bone and is compatible with the Kyphon Express access tools in the size two offering.
Kyphon Xpander II Inflatable Bone Tamp, Medtronic. Kyphon Xpander II is used when treating vertebral compression fractures with the minimally invasive Kyphon balloon kyphoplasty. The device was designed to improve pre-determined inflation patterns and exert greater lifting force than the first generation of the device.
Lanx Facet Screw System, Lanx. The Lanx Facet Screw System is intended to stabilize the spine during fusion through bilateral immobilization of the facet joints at single or multiple levels from C2-S1. The system can be used with or without bone graft and are inserted posteriorly.
MaxLock Extreme Innovative Plate and Screw System, OthoHelix. The MaxLock Extreme is a foot and ankle system with a set of universal and indication specific implants. The plates are designed with an anatomical contour and come in a verity of sizes and lengths. The implants also include compression slots, locking and non-locking screw technology.
NCB Periprostetic Plating System, Zimmer Holdings. The system's wide plates and narrow screws are designed to address fixation and poor bone quality in patients with periprosthetic fractures. The bicortical screws can be placed within a 30 degree polyazial cone and secured at any time intraoperatively using locking caps.
*NEWTON Spinal Spacer System, Binder Biomedical. The system provides spine stabilization during surgery and facilitates the fusion and includes implants designed with a large central window for optimum graft placement and a minimal-exposure tube system. It's manufactured using PEEK-OPTIMA polymer from Invibio Biomaterial Solutions.
NovaBone Putty MIS, NovaBone. The new system includes a syringe with pre-loaded NovaBone Putty and six millimeter diameter cannulas at varying lengths for bone grafting at the surgical site. The system delivers an osteoconductive matrix to stimulate the osteoblastic activity at the site.
OMNISPAN Meniscal Repair System, DePuy Mitek. The system includes a low-profile needle preloaded with two PEEK backstops and a proprietary ORTHOCORD suture. The system is designed for physicians to employ all-inside techniques, which is a less invasive surgery than the traditional inside-out or outside-in approach.
Parallax Contour Vertebral Augmentation Device, ArthroCare. The device can be used during kyphoplasty or other vertebral augmentation procedures to create the void and then fill the void with Parallax Acrylic resin. Contour utilizes a small access needle and is designed to rotate when creating the space.
*PERFX-2 Posterior Spine Stabilization System, Eden Spine. The PERFX-2 is a pedicle screw stabilization system using Dynamic Rod technology. The system is designed to preserve motion of the spine and replicate the spine's natural function.
*PERPOS PLS for Spine Surgery, Interventional Spine. PERPOS PLS is a percutaneous transfacet-pedicular compression system. The PERPOS PLS system includes a set of instruments for the percutaneous implantation of the company's BONE-LOK implant. The BONE-LOK is a one-size-fits-all implant for single- or multi-level bilateral fixation without rods or screws.
PRO-STIM Bone Graft Substitute, Wright Medical Group. The PRO-STIM is injected through a small needle or digitally implanted into the patient. The device is part of the PRO-DENSE material platform, adding a high volume of osteoinductive demineralized bone matrix to speed up the healing process.
*PyroTITAN Shoulder Implant, Ascension Orthopedics. The implant offers a bone-sparing option for patients needing shoulder joint replacement and is available in 12 different sizes. The implant is designed to extend the longevity of the hemiarthroplasty joint replacement.
*RAVINE Lateral Access System, K2M. RAVINE provides a dual flat blade platform for muscle splitting transpsoas approach. The system also offers a rigid fixation to the spine and an option for a third and fourth blade. The system was designed for optimum adaptability to the patient's anatomy.
Rejuvenate Modular Primary Hip System, Stryker. The system is also designed to enable surgeons to better personalize the implant to a patient's unique anatomy by more closely matching the biomechanics of the patient.
S4 Cervical Occipital Plating System, Aesculap. The S4 System is used to promote spinal fusion of the cervical thoracic spine and accipito-cervico-thoracic junction in patients with degenerative disease or fracture.
Sagittally Stable Spinal Fixation System, Trinity Orthopedics. The Sagittally Stable Spinal Fixation System is a monoplanar pedicle screw method, system and kit. The system is intended to help surgeons fuse the spine in an anatomical position while also maintaining the anterior column.
*SOVEREIGN Spinal System, Medtronic. SOVEREIGN is an intervertebral body fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. The SOVEREIGN device is made of polyetheretherketone so it is radiolucent on x-rays.
Spartan PEEK Suture Implant System, ArthroCare. ASpartan is a preloaded PEEK threaded anchor for use in soft tissue to bone fixation. Spartan has a 5.5-mm screw-in design for stronger pull-out strength and can be used to perform single and double row repairs.
SpeedFix Suture Anchor System, ArthroCare. SpeedFix suture anchor system is designed for the repair of labrum tears in the shoulder. SpeedFix anchors are double-loaded with ArthroCare's MagnumWire suture, which allows for independent bone locking, suture tensioning and suture locking.
SpineAssist Robotic Guidance System, Mazor Surgical Technologies. SpineAssist is a robotic guidance system that provides physicians with a secure channel of work. It can be used for a variety of spinal procedures, such as biopsies, pedicular screw placement and cement injections.
STALIF MIDLINE ALIF, Centinel Spine. The STALIF MIDLINE system includes the Lag Effect Fixation and Lumen Locking as well as ABO screw technology which guard against screw back-out. The system includes the full spectrum of implant sizes to accommodate for individual patients.
TWINFIX Suture Anchor, Smith & Nephew. TWINFIX is an anchor designed to address variation in bone density and tissue quality for rotator cuff repair in the shoulder. The new anchor is available in sizes ranging from 4.5 mm to 6.5 mm.
VariAx Fibula Locking Plate System, Stryker. The system includes a pre-contoured plate to fit the patient's individual need as well as the option to choose an appropriate angulation of locking screws. The device is 1.3mm distally and is designed to limit tissue irritation on the ankle after it is implanted.
VariLift Expandable Interbody Fusion System, Wenzel Spine. The VariLift-L is designed to be implanted as a single device using the transverse approach or bilaterally using the posterior approach. The VariLift-A is designed for bilateral implantation using the anterior approach. Both can be implanted with or without supplemental fixation.
VEGA Knee System from Aesculap. The VEGA Knee System can be used in reconstruction of a diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or reversal of failed arthroplasties. The system is designed for use with bone cement.
Versalok PEEK Rotator Cuff Anchor, DePuy Mitek. The device, which is completely radiolucent, is designed to allow sutures to be affixed without knot-tying. Additionally, the device has two mid-body wings designed for increased fixation in cancellous bone.
VERTEX SELECT Reconstruction System, Medtronic. The system posted screw module for treating patients who require fixation of the vertebrae in the upper-thoracic spine. It includes implants and general instruments to treat a variety of conditions, such as degenerative disc disease, spinal stenosis, fractures, tumors and spondylolisthesis.
VisuALIF Interbody Fusion Implant System, SpinSmith Partners. The VisuALIF is a two-piece, standalone device for use during intervertebral body fusion of the lumbar spine. The device is open-faced, allowing in situ graft placement, tactile feedback with a face plate attachment and device placement flush with the anterior aspect of the vertebrae.
*VIKOS Cervical Allograft System, K2M. VIKOS is the company's first biologics product. It was developed to support physicians treating cervical pathologies with cortical ring and cortical-cancellous implant options of several sizes. The implants are designed with lordotic options for sagittal alignment.
Vu aPOD Prime ALIF Device, Integra LifeSciences. The Vu aPOD allows physicians to utilize two fixation options: securing it with two self-tapping bone screws (which does not require additional supplemental fixation) or securing it with the SpinPlate internal buttress plate technology (which requires supplemental fixation).
Xiphos Posterior Interbody Devices, DiFUSE. Xiphos is used during intervertebral body fusion of the lumbar spine from L2 to SI. It can be used at one level or two contiguous levels for degenerative disc disease with up to Grade I spondylolisthesis.
Zenius Thoracolubar Spinal System, Medyssey. The Zenius Thoracolumbar Spinal System in titanium alloy is used for treating deformity and degenerative spinal pathologies. The system includes a 5.5 mm rod and thoracolumbar pedicle screw construct.
* indicates the device may not have been cleared by the FDA at the time of this publication
Read more coverage on orthopedic and spine devices:
- FDA to Revoke OK of Menaflex Knee Implant, Citing Meddling by Congressmen, Former FDA Commissioner
- 32 Orthopedic and Spine Devices Receive FDA Clearance in August
- FDA Sends Johnson & Johnson Letter of Warning
Apex Knee Reconstruction System, OmniLife Science. The Apex Knee System is designed to improve stability and maximize the knee's range of motion. The design was based on extensive clinical anthropomorphic analysis of male and female anatomy. It offers a wide range of primary sizes as well as specifically designed and proportioned intermediates sizes with anatomic characteristics.
*AxiaLIF 2L+ Implant System, TranS1. The AxiaLIF 2L+ is designed to make lumbar fusions around the L4-S1 region of the spine less invasive than other techniques. The new product line is the second generation of the system, first launched in 2008.
Big Foot ALIF, Pioneer Surgical. Pioneer Surgical Technology has launched the Pioneer Advantage portfolio of allograft products, including the anterior lumbar interbody fusion product Bigfoot. The products include machined allografts for cervical and anterior lumbar procedures and de-mineralized strips and cubes for spinal and general orthopedic surgery.
Ceruleau Surgical Probe, NuOrtho. The Ceruleau is designed to leave less damage on the cartilage when performing surgery for injuries or lesions on the knees and shoulders. In most severe injury cases, surgeons using Ceruleau will not need to use screws or plates for the patient.
Ceramic Hip System, Cardo Medical. The Cardo Medical Ceramic Hip System is a metal/ceramic/polymer semi-constrained nonporous un-cemented prosthesis for hip replacement. The system is used with or without bone cement and limits translation and rotation in one or more planes.
CHESAPEAKE Anterior Lumbar Stabilization System, K2M. CHESAPEAKE is an interbody device designed to stabilize the spine through an anterior approach. The system includes the tifix locking technology for screw fixation, in which each screw head forms an autogenic lock to the implant upon insertion.
*COUGAR LS Cage System, DePuy Spine. The COUGAR LS cage has a self-distracting tip and bulleted nose for a streamlined insertion. DePuy Spine also launched VIPER 2, including a versatile rod insertion options for complex and degenerative pathologies, and the PIPELINE LS, including retractor blades where the top of the retractor is radiolucent and allows for the visualization for placement of the COUGAR LS cage.
Construx Mini PEEK VBR System, Orthofix. The Construx System can be used in the thoracolumbar spine for partial vertebrectomy of diseased vertebral body resected for the treatment of tumors, for anrterior decompression of the spinal cord and the restoration of a collapsed vertebral body. It can also treat fractures in the thoracic and lumbar spine.
DuraGen Plus Dural Regeneration Spinal Matrix, Integra LifeSciences. The matrix is an absorbable and sutureless collagen onlay which can be used to repair the dura matter instead of suturing or applying a dural graft. It is used in assisting the repair of fibrous membrane surrounding brain tissue and the spinal cord.
Endoskeleton TO, Titan Spine. The Endoskeleton TO is cleared for use in posterior lumbar interbody fusion. It includes a roughened titanium surface that helps during in the fusion process. The device was designed to promote earlier bone in-growth and stability.
Equinoxe Reverse Shoulder System, Exatech. The system is designed to address scapular notching while maintaining the center of rotation on or close to the face of the glenoid.
EVOLUTION Medial-Pivot Knee System, Wright Medical Group. EVOLUTION is the next generation in Wright's medial-pivot knees, which feature more sizing options and a posterior stabilized option. The system's 'ball-in-socket mechanism' on the medial side is designed to promote stability and range of motion.
EXPEDIUM Spine System, DePuy Spine. The EXPEDIUM system includes longitudinal rods, screws, hooks, transverse and dual-rod connectors, sacral extenders and washers. The new offset system features polyaxial and fixed bolts, angulating and slotted connectors and single and multi-level plating options.
Firebird Pedicle Screw System, Orthofix. The new system is designed for treatment of patients with spinal conditions, including scoliosis and kyphosis. The system's new Direct Vertebral Rotation device provides surgeons with the option to combine rod reduction and direct vertebral rotation in one low profile instrument. The device is designed for quick intraoperative assembly and disassembly.
iDuo Knee Resurfacing System, ConforMIS. ConforMIS released the iDuo G2 patient-specific bicompartmental knee resurfacing system. The iDuo G2 was designed to provide a less-invasive alternative to total knee replacement for patients with diseases in the medial or lateral compartment or the patellofemoral joint.
Interface Acetabular System Hip Implant, Omni Life Science. The InterFace Cup System uses a locking taper design to deliver liner retention with congruency. It can be used for primary or revision total hip replacement and is intended for un-cemented fixation and single-use implantation.
Juliet OL Intervertebral Fusion Device, Spineart. This device is an implantable single or multiple component spinal device intended for intervertebral body fusion in patients with degenerative disc disease at one or two contiguous levels from L2-S1.
*KYPHON Express Curette, Medtronic. The KYPHON Express curette is available in T-tip with a torque resetting device. The device is designed to maximize control when scoring or scraping the bone and is compatible with the Kyphon Express access tools in the size two offering.
Kyphon Xpander II Inflatable Bone Tamp, Medtronic. Kyphon Xpander II is used when treating vertebral compression fractures with the minimally invasive Kyphon balloon kyphoplasty. The device was designed to improve pre-determined inflation patterns and exert greater lifting force than the first generation of the device.
Lanx Facet Screw System, Lanx. The Lanx Facet Screw System is intended to stabilize the spine during fusion through bilateral immobilization of the facet joints at single or multiple levels from C2-S1. The system can be used with or without bone graft and are inserted posteriorly.
MaxLock Extreme Innovative Plate and Screw System, OthoHelix. The MaxLock Extreme is a foot and ankle system with a set of universal and indication specific implants. The plates are designed with an anatomical contour and come in a verity of sizes and lengths. The implants also include compression slots, locking and non-locking screw technology.
NCB Periprostetic Plating System, Zimmer Holdings. The system's wide plates and narrow screws are designed to address fixation and poor bone quality in patients with periprosthetic fractures. The bicortical screws can be placed within a 30 degree polyazial cone and secured at any time intraoperatively using locking caps.
*NEWTON Spinal Spacer System, Binder Biomedical. The system provides spine stabilization during surgery and facilitates the fusion and includes implants designed with a large central window for optimum graft placement and a minimal-exposure tube system. It's manufactured using PEEK-OPTIMA polymer from Invibio Biomaterial Solutions.
NovaBone Putty MIS, NovaBone. The new system includes a syringe with pre-loaded NovaBone Putty and six millimeter diameter cannulas at varying lengths for bone grafting at the surgical site. The system delivers an osteoconductive matrix to stimulate the osteoblastic activity at the site.
OMNISPAN Meniscal Repair System, DePuy Mitek. The system includes a low-profile needle preloaded with two PEEK backstops and a proprietary ORTHOCORD suture. The system is designed for physicians to employ all-inside techniques, which is a less invasive surgery than the traditional inside-out or outside-in approach.
Parallax Contour Vertebral Augmentation Device, ArthroCare. The device can be used during kyphoplasty or other vertebral augmentation procedures to create the void and then fill the void with Parallax Acrylic resin. Contour utilizes a small access needle and is designed to rotate when creating the space.
*PERFX-2 Posterior Spine Stabilization System, Eden Spine. The PERFX-2 is a pedicle screw stabilization system using Dynamic Rod technology. The system is designed to preserve motion of the spine and replicate the spine's natural function.
*PERPOS PLS for Spine Surgery, Interventional Spine. PERPOS PLS is a percutaneous transfacet-pedicular compression system. The PERPOS PLS system includes a set of instruments for the percutaneous implantation of the company's BONE-LOK implant. The BONE-LOK is a one-size-fits-all implant for single- or multi-level bilateral fixation without rods or screws.
PRO-STIM Bone Graft Substitute, Wright Medical Group. The PRO-STIM is injected through a small needle or digitally implanted into the patient. The device is part of the PRO-DENSE material platform, adding a high volume of osteoinductive demineralized bone matrix to speed up the healing process.
*PyroTITAN Shoulder Implant, Ascension Orthopedics. The implant offers a bone-sparing option for patients needing shoulder joint replacement and is available in 12 different sizes. The implant is designed to extend the longevity of the hemiarthroplasty joint replacement.
*RAVINE Lateral Access System, K2M. RAVINE provides a dual flat blade platform for muscle splitting transpsoas approach. The system also offers a rigid fixation to the spine and an option for a third and fourth blade. The system was designed for optimum adaptability to the patient's anatomy.
Rejuvenate Modular Primary Hip System, Stryker. The system is also designed to enable surgeons to better personalize the implant to a patient's unique anatomy by more closely matching the biomechanics of the patient.
S4 Cervical Occipital Plating System, Aesculap. The S4 System is used to promote spinal fusion of the cervical thoracic spine and accipito-cervico-thoracic junction in patients with degenerative disease or fracture.
Sagittally Stable Spinal Fixation System, Trinity Orthopedics. The Sagittally Stable Spinal Fixation System is a monoplanar pedicle screw method, system and kit. The system is intended to help surgeons fuse the spine in an anatomical position while also maintaining the anterior column.
*SOVEREIGN Spinal System, Medtronic. SOVEREIGN is an intervertebral body fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. The SOVEREIGN device is made of polyetheretherketone so it is radiolucent on x-rays.
Spartan PEEK Suture Implant System, ArthroCare. ASpartan is a preloaded PEEK threaded anchor for use in soft tissue to bone fixation. Spartan has a 5.5-mm screw-in design for stronger pull-out strength and can be used to perform single and double row repairs.
SpeedFix Suture Anchor System, ArthroCare. SpeedFix suture anchor system is designed for the repair of labrum tears in the shoulder. SpeedFix anchors are double-loaded with ArthroCare's MagnumWire suture, which allows for independent bone locking, suture tensioning and suture locking.
SpineAssist Robotic Guidance System, Mazor Surgical Technologies. SpineAssist is a robotic guidance system that provides physicians with a secure channel of work. It can be used for a variety of spinal procedures, such as biopsies, pedicular screw placement and cement injections.
STALIF MIDLINE ALIF, Centinel Spine. The STALIF MIDLINE system includes the Lag Effect Fixation and Lumen Locking as well as ABO screw technology which guard against screw back-out. The system includes the full spectrum of implant sizes to accommodate for individual patients.
TWINFIX Suture Anchor, Smith & Nephew. TWINFIX is an anchor designed to address variation in bone density and tissue quality for rotator cuff repair in the shoulder. The new anchor is available in sizes ranging from 4.5 mm to 6.5 mm.
VariAx Fibula Locking Plate System, Stryker. The system includes a pre-contoured plate to fit the patient's individual need as well as the option to choose an appropriate angulation of locking screws. The device is 1.3mm distally and is designed to limit tissue irritation on the ankle after it is implanted.
VariLift Expandable Interbody Fusion System, Wenzel Spine. The VariLift-L is designed to be implanted as a single device using the transverse approach or bilaterally using the posterior approach. The VariLift-A is designed for bilateral implantation using the anterior approach. Both can be implanted with or without supplemental fixation.
VEGA Knee System from Aesculap. The VEGA Knee System can be used in reconstruction of a diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or reversal of failed arthroplasties. The system is designed for use with bone cement.
Versalok PEEK Rotator Cuff Anchor, DePuy Mitek. The device, which is completely radiolucent, is designed to allow sutures to be affixed without knot-tying. Additionally, the device has two mid-body wings designed for increased fixation in cancellous bone.
VERTEX SELECT Reconstruction System, Medtronic. The system posted screw module for treating patients who require fixation of the vertebrae in the upper-thoracic spine. It includes implants and general instruments to treat a variety of conditions, such as degenerative disc disease, spinal stenosis, fractures, tumors and spondylolisthesis.
VisuALIF Interbody Fusion Implant System, SpinSmith Partners. The VisuALIF is a two-piece, standalone device for use during intervertebral body fusion of the lumbar spine. The device is open-faced, allowing in situ graft placement, tactile feedback with a face plate attachment and device placement flush with the anterior aspect of the vertebrae.
*VIKOS Cervical Allograft System, K2M. VIKOS is the company's first biologics product. It was developed to support physicians treating cervical pathologies with cortical ring and cortical-cancellous implant options of several sizes. The implants are designed with lordotic options for sagittal alignment.
Vu aPOD Prime ALIF Device, Integra LifeSciences. The Vu aPOD allows physicians to utilize two fixation options: securing it with two self-tapping bone screws (which does not require additional supplemental fixation) or securing it with the SpinPlate internal buttress plate technology (which requires supplemental fixation).
Xiphos Posterior Interbody Devices, DiFUSE. Xiphos is used during intervertebral body fusion of the lumbar spine from L2 to SI. It can be used at one level or two contiguous levels for degenerative disc disease with up to Grade I spondylolisthesis.
Zenius Thoracolubar Spinal System, Medyssey. The Zenius Thoracolumbar Spinal System in titanium alloy is used for treating deformity and degenerative spinal pathologies. The system includes a 5.5 mm rod and thoracolumbar pedicle screw construct.
* indicates the device may not have been cleared by the FDA at the time of this publication
Read more coverage on orthopedic and spine devices:
- FDA to Revoke OK of Menaflex Knee Implant, Citing Meddling by Congressmen, Former FDA Commissioner
- 32 Orthopedic and Spine Devices Receive FDA Clearance in August
- FDA Sends Johnson & Johnson Letter of Warning