Exactech Receives FDA 510(k) Clearance for Vantage Total Ankle
Exactech received FDA 510(k) clearance to market the Vantage™ Total Ankle. Targeted clinical evaluation will commence in mid-2016, with full launch slated for 1Q17. Apr 25, 2016
Orthopaedic Industry Surpassed $46 Billion in 2015
Worldwide orthopaedic product sales reached $46.6 billion in 2015, an increase of 1.2 percent over 2014, according to ORTHOWORLD estimates. The numbers cited in the latest installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT show that industry growth slowed from the two to three percent range in recent years due to various economic and industry factors. Apr 22, 2016
Bone Solutions Signs Distribution Agreement with Next Health
Bone Solutions signed an exclusive 10-state U.S. distribution agreement with Next Health for OsteoCrete magnesium-based bone graft substitute. Apr 21, 2016
BD Divests Vertebral Augmentation Products to Stryker
BD sold its vertebral augmentation assets, including all AVAmax®, AVAflex®, AVAtex® and AVAprep® branded products, to Stryker. Financial terms were not disclosed. Apr 21, 2016
RTI Surgical Launches the Release Laminoplasty Fixation System
RTI Surgical entered the posterior laminoplasty market with launch of the Release® Laminoplasty Fixation system, indicated for central spinal cord decompression from C3 to T3. Apr 21, 2016
Cartiva Announces Positive FDA Advisory Panel Review of Synthetic Cartilage Implant
FDA’s Orthopaedic and Rehabilitation Devices Panel recommended premarket approval of Cartiva’s Synthetic Cartilage Implant for the treatment of osteoarthritis in the great toe. Apr 21, 2016
Surgeons, Distributors Diversify and Protect Revenue Streams with Orthopaedic Urgent Care
As declining margins squeeze every facet of orthopaedics and reimbursement undergoes yet another change, independent surgeons seek to diversify their practices to protect existing revenue and develop new streams. Some are aligning with or opening an orthopaedic urgent care center. In turn, the growth of orthopaedic urgent cares has attracted interest from other industry stakeholders, like major hospital systems and device distributors. Apr 21, 2016
Demographics and Distribution: Finding the Best Foreign Market for a Device
Companies that achieve success in their home market are frequently compelled to expand to international soil to take advantage of desirable demographics and less competition. However, selecting the right market for your product, and setting up an efficient and effective sales and distribution network, can be daunting tasks - especially for a young business. Apr 21, 2016
Study Results Show Benefits of SI Joint Fusion after Two Years
Results from a 2-year study of SI-BONE’s iFuse implant for sacroiliac (SI) joint fusion show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years. Apr 20, 2016
Episurf Medical Receives Expanded Reimbursement Coverage in the EU
Episurf Medical’s Episealer® procedure received expanded reimbursement coverage in the U.K., Netherlands and Belgium. The patient-specific implants and Epiguide® drill guides are designed to treat localized cartilage injury in joints. Apr 20, 2016
