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Suspension Orthopaedics Gets FDA Clearance for Surgical System


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ARNOLD, MD - Suspension Orthopaedic Solutions announced it has received FDA 510(k) clearance for two new products - its Distal Clavicle Fracture Fixation System™ and a new plate designed to address repair of mid-shaft clavicle fractures.

The new 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.

The Distal Clavicle Fracture Fixation System addresses a widely acknowledged challenge for surgeons, 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. 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 joint separation. These injuries are often sports-related, typically occurring in physically active people age 18 to 55 who participate in activities such as bicycling, football, skiing and snowboarding.

"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," said Robert S. Collins, Suspension's CEO.

Suspension's products are immediately available and are distributed through its distributor partners.

"The combination of these new FDA clearances and our recently closed financing with Axiom Equity Partners will allow us to expand Suspension's core technology to more than 30 indications throughout the body encompassing 1 million procedures annually in the U.S. alone," Collins said.

About Suspension Orthopaedic Solutions
Based in Arnold, Md., Suspension Orthopaedic Solutions, Inc. is a privately held medical device company bringing meaningful innovations to surgeons who manage traumatic injuries of the musculoskeletal system. The company's initial products, which support percutaneous and open surgical techniques, were conceived by an active orthopedic surgeon and are designed to address injuries to the shoulder suspensory complex.

Subsequent development of the company's T-Loc Technology will target multiple soft-tissue injuries throughout the body that are the focus of an estimated 1 million surgical procedures in the U.S. each year.

For more information, call 410-970-6321 or visit www.suspensionortho.com.

Posted by Sean Fenske, Editor-in-Chief, MDT

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