Titanium foam implants cleared for joint replacement surgeries
DePuy Orthopaedics, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of GRIPTION® TF (A) in two new implant systems for complex joint replacement procedures.
The manufacturer reports that components of the GRIPTION TF Acetabular Augment System for hip replacement are engineered to provide a wide range of options and configurations so that each patient’s implant components can be customized at the time of surgery.
The Universal GRIPTION TF Cones for knee replacement surgery can be used with the tibial or femoral component in patients with marked bone loss. According to the manufacturer, this provides surgeons performing complicated revision total knee replacements with additional options. Available in a wide range of sizes, the GRIPTION TF Cones are fully compatible with DePuy’s Sigma® Knee System.
For more information, visit www.depuy.com
Dedcated musculoskeletal MRI system
The G-scan (B) from Esaote is a weight-bearing magnetic resonance imaging (MRI) system said to be capable of scanning patients in a conventional supine position or at any angle up to 90 degrees. The G-scan features specific musculoskeletal imaging sequences and is designed to be easily installed in an orthopaedic office.
The G-scan covers all applications: foot and ankle, knee, hip, L- and C-spine, shoulder, elbow, and hand and wrist. The manufacturer says that the magnet can be tilted from the horizontal to vertical position, enabling imaging of the patient in the weight-bearing position and thereby allowing the user to visualize the actual condition of pathologies.
For more information, visit www.esaote.com
Smaller-sized vertebral balloon for spinal fracture repair
CareFusion’s AVAmax® Vertebral Augmentation (C) system includes an 11-gauge vertebral balloon designed to allow spine surgeons and interventional radiologists to repair vertebral compression fractures that have been historically more difficult to treat due to their size and location in the spinal column (including smaller vertebrae). The smaller design helps make the procedure less invasive for patients without compromising the clinical efficacy of the device because it still meets the pressure and volume requirements of legacy vertebral balloons, according to the manufacturer. In addition, the tungsten radiopaque tip enables improved visibility under imaging, helping to ensure safe deployment of the balloon in the vertebral body.
For more information, visit www.carefusion.com
Interference fixation device for ACL reconstruction
The ExoShape™ CL (D) from MedShape Solutions, Inc. is a two-part PEEK Altera™ interference fixation device designed to simplify and improve soft-tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. The device features a nonrotational deployment technique that is reported to preserve the surgeon’s desired soft-tissue graft bundle orientation and tension during single-tunnel double-bundle procedures. In addition, the ExoShape’s deployment gun and deployment cartridge combination utilizes a closed force loop for sheath expansion, eliminating the need for forward force on the sheath and allowing the surgeon to confirm desired graft tension prior to final device deployment, says MedShape.
For more information, visit www.medshape.com
Revision hip system nets FDA clearance
Engineered to deliver a high level of implant strength, DePuy Orthopaedics, Inc.’s RECLAIM™ Revision Femoral Hip System (E) has been cleared by the FDA for use in cementless hip revision surgery. According to the manufacturer, RECLAIM’s modular design features novel instrument technology, which may improve intraoperative handling, flexibility, and efficiency, and reportedly offers surgeons numerous options to treat a patient’s unique pathology while simplifying the instrumentation required in surgery.
For more information, visit www.depuy.com
Acellular matrix scaffold targets subchondral defects
Bacterin has received FDA permission to market OsteoSponge®SC as a subchondral bone void filler. OsteoSponge®SC is an acellular matrix scaffold made from donated human bone that is used to replace a patient’s damaged subchondral bone. Bacterin says the OsteoSponge®SC process is cost effective, minimally invasive with excellent handling characteristics, and provides surgeons with more options in the treatment of subchondral defects.
For more information, visit http://www.bacterin.com/
Porous metal cervical interbody device
The TM-S Trabecular Metal™ Cervical Interbody Fusion Device from Zimmer reportedly provides an osteoconductive scaffold that supports bony ingrowth and vascularization into the implant. The TM-S Cervical Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The device is designed to treat the cervical spine of patients with degenerative disk disease with or without radicular symptoms at one level from C2-T1.
For more information, visit www.zimmer.com
Biologic products for treating bony defects
Pioneer Surgical Technology’s new portfolio of biologic products is designed to be used in the extremities and pelvis. The portfolio includes Legato, a resorbable, collagen-based implant that acts as a scaffold for the ingrowth of new bone and is designed to have broad appeal in repairing bony defects in the extremities and pelvis, including those caused by trauma. Legato reportedly forms a cohesive and adhesive product that can be easily shaped to defects while maximizing direct contact with host bone.
For more information, visit www.pioneersurgical.com