The U.S. Food and Drug Administration has given the 510 (k) clearance to Cardo Medical’s Align 360 Total Knee System. The product will be available in the market by mid-2009. The system features a distinct modular approach and a common instrumentation system. The novel minimally invasive solution is designed to help surgeons in achieving better surgical outcomes. Now, the Align 360 platform becomes a complete solution for of uni-compartmental, bi-compartmental and tri-compartmental arthritis.

The U.S. Food and Drug Administration has given 510(k) clearance to Amedica Corporation, SEEplate(TM) Cervical Plate system. The system incorporates features which aim at giving surgeons an alternative to the current surgical procedures that are being followed. It facilitates anterior screw fixation, thereby suiting the patient anatomy. In this way, a more consistent supplemental fixation result can be achieved for various applications such as including degenerative disc disease and spinal stenosis.

The U.S. Food and Drug Administration has cleared Biospace med’s EOS X-ray imager for market launch. The device is helpful in procedures related to spine, hip and knee. EOS captures head-to-toe images of patients in a weight-bearing position. The radiation dosage is 10 times lesser than a conventional X-ray and 1000 times less than a CT scan. Additionally, the new stereos and measurement workstation enable 3D reconstruction and reduce the time taken for surgical planning, making orthopedic procedures simpler.

The US Food and Drug Administration has expanded Titan Spine‘s ENDOSKELTON® TA Vertebral Body Replacement Device (VBR) 510k to include an Interbody Fusion Device indication. The expanded 510K indication, means that the device is approve for the use in skeletally mature patients with Degenerative Disc Disease (DDD). Patients should have received six months of non-operative treatment prior to treatment with the devices. The device may be used with supplemental fixation. It will enable the surgeon to utilize the Endoskeleton TA as an Interbody Device while taking off the VBR label. The device will make the surgeons comfortable by providing them the option to use the device in a stand-alone setting.

Medtronic Inc. has received approval to market two smaller kit sizes of INFUSE® Bone Graft for use in certain spinal fusion and dental regenerative procedures. The FDA has approved two additional configurations of INFUSE Bone Graft: XX Small (0.7cc) kit and X Small (1.4cc) kit. These new sizes will be available for clinical use from June.

The FDA has cleared Osteotech Inc.’s Plexur P biocomposite for use in spinal applications as a bone void filler and graft extender. Osteotech has already received FDA clearance for Plexur P for use in filling bony voids of the pelvis and extremities. The biocomposite has been used in tibial plateau fractures, tibial osteotomies and foot and ankle procedures. The company aims to immediately offer our Plexur P(TM) product to spine surgeons.

VertiFlex Inc. has announced receiving 510K clearance from the FDA for the Silverbolt™ Percutaneous Multi-Level Rod (MLR) System. The system delivers two rods in one screw for multi-level spine stabilization applications. The Silverbolt MLR System offers an alternative to other more invasive approaches that cause more blood loss and late patient recovery by percutaneously stabilizing multiple vertebral levels of the spine.

Osteotech Inc. has received FDA approval for its 510(k) submission for its Plexur M(TM) Biocomposite. Plexur M is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M is remodeled and replaced by host bone. When heated, Plexur M becomes moldable and pliable, which allows surgeons various options for use during surgery. During the cooling process, Plexur M hardens, providing a versatile porous scaffold to help in regeneration of damaged and diseased bones.

Osteotech’s president and CEO Sam Owusu-Akyaw has indicated that the company intends to file an additional submission for the use of this product in spinal applications during the second quarter of the year.