New Jersey based Extremity Medical, LLC has announced that it has received 510K clearance from the FDA for the CarpalFiX™ Fusion System which it says is intended for use in the surgical treatment of a wide variety of hand and wrist patients. The company claims its device delivers superior compression and stable fixation for fusion while remaining zero profile and avoiding damage to vital articular surfaces.
There are many types of fusion procedures performed in the hand and wrist with fixation challenges in intracarpal, radiocarpal, and carpometacarpal fusions varying from patient to patient. Extremity Medical says traditional plate, screw and wire fixation systems often fall short in delivering compression, stability, and ease of delivery with patients often immobilised for lengthy periods. CarpalFiX is the result of a design process specifically focused on addressing these “unmet needs” and, according to the company that developed it and is marketing it, delivers a useful, new, and versatile modality of fixation for hand and wrist surgeons.
Designed specifically for the small bones of the hand and wrist, Extremity Medical says its system delivers superior compression and stable fixation for fusion while remaining zero profile and avoiding damage to vital articular surfaces. Consequently the product is claimed to reduce non union, need for hardware removal, and to provide an earlier return to normal activities for patients. Improvements in these areas are expected to reduce the overall cost of treating wrist patients, an important consideration in the design process.
The CarpalFiX Fusion System already has CE mark approval and is currently releasing the product in select markets around the world.
Jamy Gannoe, President, CEO and Co‐Founder of Extremity Medical, stated “This FDA approval and global product release are significant milestones in the strong growth of Extremity Medical. With the new CarpalFiX and the previously released XMCP™ Intra Osseous Devices, our company is positioned to attack the hand, wrist and digit fixation market with a new, useful, highly differentiated portfolio of implants.”
Source: Extremity Medical, LLC.