Musculoskeletal News Roundup 2-Jun-11
BY LAUREN UZDIENSKI, JUNE 2, 2011
Regulatory
BioPoly received CE mark certification for its BioPoly RS Partial Resurfacing Knee Implant, which is made from a proprietary material composed of a synthetic polymer and a naturally occurring polysaccharide. The company will launch the product in Europe later this year.
ConforMIS received CE mark certification for the iTotal CR, the company's patient-specific total knee resurfacing system.
Nimbic Systems received 510(k) clearance to market the Air Barrier System, which is designed to prevent contamination at an incision site by creating a "localized zone of protective air." The product is intended to be used during joint replacement procedures.
ORTHOCON received 510(k) clearance to market the HEMASORB Apply, which consists of a custom-designed applicator preloaded with HEMASORB Absorbable Bone Hemostat Matrix. The company says that currently-marketed bone hemostat products require surgeons to use their fingers or surgical instruments for application.
ReGen filed suit against the FDA in D.C. court, alleging that the rescission of Menaflex was "arbitrary, capricious, an abuse of discretion and not in accordance with law."
Vidacare received expanded CE mark clearance for use of the OnControl System in bone and vertebral body biopsies. The OnControl System was previously approved in the EU for use in bone marrow biopsies and delivery of bone cement.
Product Introduction & Update
ConforMIS announced that the first surgeries using the iTotal CR knee resurfacing system have been completed in Massachusetts, California and Texas. The iTotal generates individualized implants and instruments based on a patient's imaging data.
Exactech launched the Proliant Polyaxial Pedicle Screw system, the first spinal system to be developed in-house. The product is intended for use in the thoracolumbar spine.
Zimmer launched its CLS Brevius Stem with Kinectiv Technology at the 12th annual European Federation of National Associations of Orthopaedics and Traumatology (EFORT) meeting in Copenhagen. The company says the system features modular neck options designed for independent intraoperative adjustments. Also at EFORT, Zimmer is showcasing their Zimmer Patient Specific Instruments (PSI), which utilize MRI technology and pre-operative planning tools to create customized pin guides unique to each patient's anatomy. Further, the company launched the Maxera Cup outside the U.S. The device is designed for younger, more active patients and features a large-diameter femoral head that provides for "increased range of motion and enhanced stability."
Appointments
DJO Global appointed Michael P. Mogul as the Company's new chief executive officer, effective June 13, 2011. Mr. Mogul will succeed Les Cross, DJO's current President and CEO, who will assume the role of Chairman. Mr. Mogul most recently served as Stryker Corporation's Group President, Orthopaedics. Stryker announced that Kevin Lobo, Group President, Neurotechnology and Spine will take over the role of Group President, Orthopaedics, on June 13, 2011.
