In short
The FDA has granted 510(k) clearance for two products designed to aid in the repair of the shoulder made by Maryland company Suspension Orthopaedic Solutions, Inc. The products are a Distal Clavicle Fracture Fixation System and a Mid-Shaft Clavicle Plate.
Product features
According to a company release, both products build on Suspension’s separate, previously cleared products that address two injuries to the shoulder suspensory complex: Clavicle fractures and Acromioclavicular (AC) joint separation. These injuries are often sports-related, typically occurring in physically active people ages 18 to 55 who participate in activities such as bicycling, football, skiing and snowboarding.
Company co-founder, orthopaedic surgeon Dr. Jeffrey Gelfand, explained that the Distal Clavicle Fracture Fixation System addresses a widely acknowledged challenge for surgeons, which is to effectively secure fractures of the distal portion of the clavicle. Existing technologies have been associated in the clinical literature with inadequate fixation, suture abrasion and more time-consuming surgery.
He says that the new Mid-Shaft Clavicle Plate creates a complete clavicle system for surgeons treating these injuries.
The Distal Clavicle Fracture Fixation System features Suspension’s patent-pending T-Loc Technology which enables knotless, protected and precisely controlled tension for secure fixation of multiple soft-tissue injuries.
Company comments
The two devices, made of stainless steel, “can be used in combination for the repair of distal-clavicle fractures,” according to company CEO Robert S. Collins. “These two new FDA clearances will expand the availability of our confidence-inspiring solutions for orthopaedic surgeons who treat difficult shoulder injuries, and reflect Suspension’s core mission of bringing meaningful innovation to challenging orthopaedic injuries.”
Collins, co-founder of the company, says that the technology is applicable to more than 30 indications throughout the body. This would encompass a million procedures annually in the U.S. alone. He also says that the FDA clearances, will help to allow the firm to apply its core technology to other conditions.
European plans
We’ve asked Suspension Orthopaedics what their European status and plans are and are yet to hear back from them, so will provide an update when available.
Source: Suspension Orthopaedics Inc
published: February 17, 2012 in: Approval/Clearance, Companies, Products, Regulatory, Shoulder, Trauma