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Published 12/1/2010

Industry news...

FDA clearances

The following devices have recently received clearance from the U.S. Food and Drug Administration (FDA):

  • The VisuALIF (A) from SpineSmith Partners is a two-piece, stand-alone device indicated for intervertebral body fusion of the lumbar spine. The device is available in a range of product sizes and configurations. For more information, visit www.spinesmithusa.com
  • The NovaBone MIS Delivery System is designed to improve delivery of bone graft substitutes through a syringe preloaded with ready-to-use NovaBone Putty and 6-mm diameter cannulas at varying lengths. It is approved for use in orthopaedic surgeries of the extremities, pelvis, and posterolateral spine. For more information, visit www.novabone.com
  • ArthroCare Corp’s Parallax® Contour® Vertebral Augmentation Device (Contour) (B) is indicated for void creation in a vertebral body followed by injection of bone cement during kyphoplasty. Contour uses a movable, curved stylet to displace bone and create a void. The device utilizes a small access needle and is manually advanced and rotated to create the space. For more information, visit www.arthrocare.com
  • The VariLift Interbody Fusion System (VariLift-L and VariLift-A) from Wenzel Spine is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had 6 months of nonsurgical treatment. The system is intended for use at either one level or two contiguous levels for the treatment of degenerative disk disease with up to Grade I spondylolisthesis. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion. For more information, visit www.wenzelspine.com
  • DiFUSION Technologies Inc.’s new Xiphos™ line of posterior interbody devices is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had 6 months of nonsurgical treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disk disease with up to Grade I spondylolisthesis. The Xiphos™ System of implants is also indicated for use to replace a vertebral body that has been resected or excised (ie, partial or total vertebrectomy) due to tumor or trauma/fracture. The system is intended for the thoracolumbar spine (from T1 to L5) and for use with supplemental internal fixation. For more information, visit www.DiFUSIONtech.com
  • The Vu aPOD™ Prime ALIF device from Integra LifeSciences may be used with or without additional supplemental fixation in spinal fusion procedures. It can be secured in place with two self-tapping bone screws that require no additional supplemental fixation or may be secured with SpinPlate™ internal buttress plate technology, which requires supplemental fixation. For more information, visit www.integrasurgical.com

Arthroscopic surgery fluid thermometer
The Ambient® ArthroWand® Collection from ArthroCare is a portfolio of radiofrequency devices designed to provide orthopaedic surgeons with accurate, real-time temperature monitoring of the circulating fluid within the arthroscopic surgical environment. The collection includes the Ambient Super MultiVac® 50, the Ambient Super TurboVac® 90
(C), the Ambient CoVac® 50, and the Ambient CoVac® 70. According to the manufacturer, the Ambient thermocouple technology allows surgeons to view current temperature measurements of the saline fluid in the shoulder and knee, when paired with the Quantum™ 2 Controller System.

For more information, visit www.arthrocare.com

Cervical allograft system
The VIKOS™ Cervical Allograft System
(D) from K2M was developed to support surgeon treatment of cervical pathologies with cortical ring and cortical-cancellous implant options in a wide range of sizes. The implants are designed with lordotic options for proper sagittal alignment and are treated with LifeNet Health’s proprietary PRESERVON® technology for storage at ambient temperature.

For more information, visit www.K2M.com

Reinforcement matrix for surgical tendon repair
Integra LifeSciences claims that its Inforce® Reinforcement Matrix, with FortaFlexTM Technology, may be used for any type of tendon injury that requires surgical reconstruction, reportedly providing a durable reinforcement during the healing phase of a repaired tendon. Composed of a biocompatible, purified collagen matrix, it is designed to provide an organized scaffold that facilitates cellular attachment and integration of the implant at a controlled rate of in situ remodeling.

For more information, visit www.integralife.com

Spinal deformity module introduced
Orthofix International has launched a new spinal deformity correction module based on the Firebird™ pedicle screw system. The system’s Direct Vertebral Rotation (DVR) device provides surgeons with the opportunity to combine rod reduction and direct vertebral rotation in one low profile instrument and is also intended to provide quicker intraoperative assembly and disassembly.

For more information, visit www.orthofix.com

Spinal offset correction system
DePuy Spine recently launched a new offset technology system that integrates with its EXPEDIUM® Spine System
(E) of longitudinal rods, screws, hooks, transverse and dual-rod connectors, sacral extenders, and washers. The new EXPEDIUM Offset System for spinal offset correction features a variety of polyaxial and fixed bolts, angulating and slotted connectors, and single and multilevel plating options for a customized fit.

For more information, visit www.depuy.com

Allograft promotes bone regeneration in the spine
The Alphatec Spine PureGen Osteoprogenitor Cell Allograft is designed to facilitate bone regeneration and fusion in the spine. The manufacturer states that it is adult stem cell, collected from live, healthy donors, that provides cellular and growth factors needed for osteogenesis, without the potential complications of autograft.

For more information, visit www.alphatecspine.com