FDA Clears Two New Clavicle Repair Technologies

The FDA has granted 510(k) clearance for two products designed to aid in the repair of the shoulder made by Arnold, Maryland-based Suspension Orthopaedic Solutions, Inc. One product is the Distal Clavicle Fracture Fixation System and the second is the Mid-Shaft Clavicle Plate.

The two devices, made of stainless steel, “can be used in combination for the repair of distal-clavicle fractures,” company CEO Robert S. Collins told OTW. “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.”

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.

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, combined with the company’s recently closed financing with Axiom Equity Partners, will allow the firm to apply this core technology to other conditions.

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.

Both products build on Suspension’s separate, previously cleared products that address two injuries to the shoulder suspensory complex: clavicle fractures and AC [acromioclavicular] joint separation, he added. 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.

Suspension Orthopaedic Solutions, Inc. is a privately held medical device company that lists as its goal the bringing of meaningful innovations to surgeons who manage traumatic injuries of the musculoskeletal system. The company was founded in 2008.