Cartiva Announces 510(k) Clearance for ProxiFuse Hammertoe Correction System

— Cartiva, Inc., (the “Company”) a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has received 510(k) clearance for its ProxiFuseTM Hammertoe Correction System(“ProxiFuse”). The ProxiFuse system, specifically developed for hammertoe fusion, is used for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The ProxiFuse system combines several unique features into a single device. Tiny Nitinol anchors on each side of the joint are secured into the bone, connected by a strong, self-locking suture fiber. Once tightened, the ProxiFuse system is designed to deliver continuous compression across the joint to be fused. A small PEEK body provides rigidity across the fusion site. PEEK, which is radiolucent, allows clinicians to monitor the healing progress with X-ray images, a process that can be obscured by standard radiopaque metal implants.

Hammertoes, deformities of the second, third or fourth toe that cause the toe to bend at the middle joint instead of pointing forward, are one of the most common deformities of the lesser toes. One of the more common surgical procedures to treat this condition is fusing the joint, in which the ends of the bone are cut and the toe is straightened. Pins, screws or other implants are used to keep the toe straight while the bone ends heal together. In the United States, approximately 600,0001 annual surgical implant procedures are performed to treat hammertoes. While multiple fixation methods have been used to achieve a stable correction, the most common method has traditionally been the use of a pin-like device known as a Kirschner wire, or “K-wire.” K-wires have been associated with complications including broken hardware, loosening, bending, migration and pin tract infection. Furthermore, patient dissatisfaction can be high as the K-wire protrudes from the tip of the toe during the four to six week healing process.

“We are very excited to announce the clearance of the ProxiFuse, the first intramedullary hammertoe implant designed to maintain continuous bone to bone contact through an innovative suture locking system,” said Timothy J. Patrick, president and chief executive officer of Cartiva. “We believe our system resolves many of the shortcomings of existing products, such as fixation and stability, and could provide an attractive option for patients suffering from this painful condition.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva recently announced completion of the MOTION Study, a 236 patient, randomized, prospective study of the Company’s synthetic cartilage implant for the treatment of osteoarthritis of the great toe. Cartiva’s primary investor is New Enterprise Associates. Additional information is available on the Company’s website at www.cartiva.net.

1 1. “US Market for Small Bone & Joint Orthopedic Devices,” published November 2014 by iData Research Inc.

Read more here: http://www.heraldonline.com/2015/01/07/6679245/cartiva-announces-510k-clearance.html?sp=/100/773/385/#storylink=cpy

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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One Comment

  1. My plantar fasciitis is so much better and I felt the healing almost immediately. I say healing because with me using the inserts my feet are feeling so much better even when barefoot. I can get out of bed and walk in the morning with no problem. For over a year I was trying all sorts of inserts at the drug store and went for therapy, but no real change. Orthofeet inserts worked right away. I have had them a month and I ordered a second set just so I won’t be without them. I also got the hammer-toe which I love too. I use them as shoes. Maybe you will come out with shoes, I hope 🙂

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