Adoption of Total Ankle Prostheses Pushes Forward

In recent years, patients have been seeking surgical options that provide better range of motion. Total ankle replacements offer patients both a wider range of motion and a procedure that minimizes bone loss versus fusion. Tornier's (Edina, MN) Salto Talaris total ankle prosthesis, which has been on the U.S. market since December 2006, recently surpassed the 3000 implant mark in the United States.

Back to Basics for FDA

FDA has been talking about transparency for years, but I think we all can agree that there are many aspects of regulations, guidances, and policies in general that are murky.

Sonoma Orthopedics Draws Attention to Wrists and Collarbones

Hips, knees, and the spine are the buzz words in orthopaedics, but there are plenty of other bones that are getting more attention from companies. One of the younger companies that has technologies outside of the big three categories is Sonoma Orthopedic Products Inc. (Santa Rosa, CA), which treats wrist and clavicle fractures.

FDA Rescinds Menaflex Knee, What About Other Devices on the Market?

Could FDA's decision to rescind its 510(k) clearance of Regen Biologics's Menaflex Collagen Scaffold affect other devices that are currently on the market? The agency says no in a news release sent out yesterday. The Menaflex device was cleared in December 2008 and controversy has since surrounded the product.

Trinity Ortho Gets Patent for Spinal Fixation Device

Trinity Orthopedics LLC (San Diego) has received a Patent of Allowance for its monoplanar pedicle screw method, system, and kit. The company currently markets a posterior fixation system, ReStor, which is designed to help surgeons fuse the spine in an anatomical position while maintaining the integrity of the anterior column, according to James Marino, MD, the company's founder (He also founded NuVasive). Trinity has three other patents, along with 18 U.S.

Etching Creates New Surfaces for Spinal Implants

A new photo chemical etching process from Tecomet can be used on spinal and small extremity implants. Tecotex enables improved primary fixation, enhanced bone on-growth, and a rough surface for an improved grip. The process is a computer-generated, 2-D and 3-D surface texture. The 3-D textures are designed to optimize implant fit, stability, bone adhesion, and service life. The process also provides more accurate coatings on small implants compared to conventional porous and spray coatings.

Onyx Medical Breaks Ground on New Site

Memphis-based Onyx Medical Corp. is establishing a new facility that will increase its headquarters to 53,000 sq ft (expandable to 72,000 sq ft). The company currently operates at a 30,000 sq-ft plant, and the new facility is expected to open next spring. The new site involved a $6.5 million investment, which included the building and capital expansion. It also will create at least 17 new jobs. Onyx manufactures drill bits, screws, pins, and wires for orthopaedics.