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
