The FDA has approved Austin surgical device maker LDR’s ROI-C cervical cage. This product helps in standalone cervical fusion surgeries, making it less necessary to use thick cervical plates that contribute to dysphagia or difficulty swallowing. LDR CEO Christophe Lavigne said “The entry of the ROI-C cervical cage into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies.”

Drug maker Bristol-Myers Squibb has received the FDA approval for a broader labeling of its rheumatoid arthritis drug, Orencia. Orencia can now also be used to treat patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration. Orencia was initially approved for the treatment of moderate-to-severe rheumatoid arthritis patients who did not respond to other drugs.

MAKO Surgical Corp. has announced that it received two 510(k) clearances from the US Food and Drug Administration to market both the Company’s proprietary Version 2.0 Tactile Guidance System(tm) (TGS(tm)), branded as the MAKO RIO(tm), and its bicompartmental knee resurfacing implant system, branded as RESTORIS(r) MCK. MAKO currently expects to commercially launch both the RIO(tm) system and the RESTORIS(r) MCK system in the first half of 2009. Obtaining the FDA 510(k) clearance for each of these products represents the achievement of a key milestone towards the continuing commercialization of innovative technology that restores patient quality of life.

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 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.