Category: Foot Surgery

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FDA Approves Accu-Joint Hemi Implant, a Hemi-arthroplasty Metatarsal Head or Phalangeal Base Implant for the Metatarsophalangeal (MTP) Joint

Accufix Surgical TM today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to distribute its patented Accu-Joint system, a revolutionary new approach intended to enable full restoration of MTP function and motion, with no resecting or weakening of hard bone. The unique, non-weight bearing implant, allows surgical podiatrists to choose joint preservation over joint fusion for their patients. The Accu-Joint is intended to functionally and accurately restore arthritic toe joints, while allowing original anatomic bone structure to remain intact. It is also intended to be implanted with Hallux Valgus correction, providing that procedure is being performed.

Breakthrough Benefits

The Accu-Joint system consists of two patented technologies that separate it from competitors.

A unique two-stage MTP joint reamer removes worn cartilage, smooths bone spurs and countersinks the hard subchondral bone end of the toe joint, resulting in complete resurfacing for precise implant seating and bone ingrowth, preserving bone anatomy and bone length. At the same time, second-stage blades produce 360-degree clearance around the implant articular edge, allowing the implant to articulate in a smooth manner.

Secondly, the implants include cancellous threaded, solid stems – not cannulated – intended to provide rigid fixation and help prevent influx of infection into the medullary canal, along with grooves and scalloped edges under the articular head of the implant to allow bone ingrowth for reliable anti-rotation. The threaded “barrel” of the stem, just beneath the articular surface, transfers all stress forces off the stem, and away from the softer medullary canal, into the hard subchondral bone where it is rigidly fixated. The implants are sized smaller than the diameter of the bone end, which together with 4-points of internal rigid fixation, is intended to ensure that the bone – not the implant – bears the full weight of the body, while delivering the strength and implant stability necessary for full foot function.

True Anatomical Joint Preservation

“As a practicing podiatrist for 36 years, I have been dissatisfied with joint replacement implant options for my patients.” recalls Dr. Glenn C. Vitale, the inventor of the Accu-Joint. “I have surgically removed many failed implants and have chosen not to use any of the joint implants that are currently on the market today.”

“We finally have the opportunity to choose true anatomical joint preservation over joint fusion.” Fusions represent approximately 80% of current MTP procedures, yet are prone to reduced range of motion and can inhibit quality of life and limit the choice of shoe gear.

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Carbon22 receives FDA clearance of the Creed™ Cannulated Screw System

Carbon22’s ortholucent manufacturing technology offers several key benefits, including radiotransparency that greatly improve visualization of bony structures.

ENGLEWOOD CLIFFS, NJ, UNITED STATES, December 20, 2020 /EINPresswire.com/ — Carbon22™, a GLW, Inc. company, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market the Creed™ Cannulated Screw System, a portfolio of unique, see-through “ortholucent” bone screws used for foot and ankle surgery. The Creed System was developed in collaboration with the Carbon22 consortium, a select group of orthopedic and podiatric surgeons.

The Creed system is a streamlined, multi-component platform featuring a distinctive, proprietary hybrid screw composite, consisting of a titanium core with an overmold of Solvay Zeniva® PEEK resin. Carbon22’s ortholucent manufacturing technology offers several key benefits, including radiotransparency. While using medical imaging (both during and after surgery), the radiotranslucent properties of these novel headed and headless compression screws greatly improve visualization of bony structures. The Creed screws are offered in a comprehensive selection of diameters (2.5, 4.3, 5.6 and 7.4mm) that are available in a broad range of lengths.

Carbon22 has created a bridge between materials science and device design, positively transforming the performance, manufacturing process and logistics of implant systems. These devices drastically improve cost-effectiveness, while maintaining, or improving patient outcomes.

“As surgeons, we continue to develop effective, skill-based surgical approaches to improve patient outcomes; however, device innovation has not kept up – until now,” noted Dr. Carroll P. Jones, director of the Foot and Ankle Fellowship Program at OrthoCarolina. “The Creed System is a pioneering device that provides a significant clinical advantage over traditional metal implants by radically improving intraoperative and postoperative visualization of bones and joint spaces.”

With a widened cannulation, Creed screws accept larger diameter k-wires and feature an enhanced self-drilling, self-tapping cutting screw tip that is unique to Carbon22. Combined, these features help limit k-wire bending and reduce the amount of bone chips displaced by the screw, allowing the surgeon to implant with less effort.

Dr. A. Holly Johnson, orthopedic surgeon at New York City’s Hospital for Special Surgery, stated, “The Creed System is a long-awaited advancement in cannulated screw design. Carbon22’s ortholucent technology has the potential to greatly improve our ability, as surgeons, to assess post-operative healing.” Designed for maximum efficiency, the Creed screws and instruments are packaged sterile and surgery ready. Disposable instrument kits are available for all screw sizes, eliminating reprocessing costs. “Unlike surgical systems that are used repeatedly in hundreds of surgical procedures, Carbon22’s Creed System ensures that every patient is treated with a sterile, single-use implant and new instruments functioning at their peak condition,” commented Axel Cremer, Chief Technology Officer for Carbon22.

Dr. Lowell Weil Jr., CEO of the Weil Foot & Ankle Institute, emphasized that “Carbon22 has taken the next step by targeting its manufacturing processes and production costs, allowing it to provide the Creed System at the same price or lower than other manufacturers’ conventional titanium screws.” This pricing flexibility will allow the company to aggressively penetrate and disrupt the U.S. foot & ankle implant market, estimated to be greater than $1 billion.

Carbon22 and GLW have an exclusive agreement with Solvay S.A. for the future development of medical-grade polymers.

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About Carbon22, a GLW Inc. company

Carbon22 is a privately held company, focused on the design and development of cost-effective, high-margin implant and instrument solutions for various musculoskeletal foot & ankle applications. Carbon22 and its products are commercialized in the US market through exclusive distribution and education agreements with Novastep, Inc.

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Stryker’s T2 ICF Nail System Offers Surgeons New Option for Patients Suffering from Serious Foot Conditions

Media Release:

MAHWAH, N.J., September 28, 2020—Stryker’s Trauma & Extremities division today announced the launch of its T2® ICF Intramedullary nailing system, offering a solution for patients suffering from serious foot conditions such as Charcot foot—a condition associated with diabetes resulting in poor bone quality, possible nerve damage and potential foot ulcers.1

The T2 ICF system is a stable product that provides a surgical option designed to prevent nail back out and promote fixation and accuracy. It is estimated that a leg is amputated every 30 seconds globally, and 85% of these amputations are the result of diabetic foot ulcers.2

“We are always looking for ways to improve fixation strategies in Charcot patients, as they tend to have poor bone quality and often end up needing limb-salvage procedures,” said Vinod Panchbhavi*, MD, FACS, FAOA, FABOS, FAAOS, Professor and Chief of Ankle & Foot Surgery, UTMB Health. “The T2 ICF nails are lightweight and sturdy, are easy to use.”

“This medial and lateral column nail provides rigid fixation with the ability to apply up to 10 millimeters of compression through the nail3,” said William Simon*, DPM, Bayview Physicians Group, and designer of the T2 ICF nail. “The stable nail is designed to be compatible with cross screws to help prevent nail back-out4 and the large nail diameters are intended to help prevent nail breakage3.”

The T2 ICF Intramedullary nailing system can also be used to treat other conditions such as fracture fixation, osteotomies, non- and mal-unions, and fusions.

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Paratrooper™ Plantar Plate System Receives 510(k) Clearance – 1st Dedicated System Allowing Surgeons to Repair the Plantar Plate Through Either a Dorsal or Plantar Approach

ENGLEWOOD, Colo., Feb. 7, 2020 /PRNewswire/ — The Paratrooper™ Plantar Plate Repair System was developed to allow surgeons to use a dorsal or plantar approach to the plantar plate repair procedure using a single, all-inclusive kit.

The Paratrooper™ Plantar Plate Repair System uses an all-suture anchor implant that can be fixed into bone or soft tissue. By using an all-suture implant, the surgeon can perform the plantar plate repair using a variety of fixation and approach techniques, while preserving surrounding bone and tissue. When the Paratrooper™ suture implant is inserted and tensioned, the implanted suture “sock” will contract and form into a low profile, flat anchor that will prevent the implant from pulling out of the site.

Surgeons face a variety of challenges and complications in plantar plate repair using the dorsal and plantar approach:

  • Exposure to the plantar plate from the dorsal approach
  • Difficulty implanting into bone or soft tissue
  • Step-heavy procedure with complicated instrumentation

The Paratrooper™ Plantar Plate Repair System was designed with these challenges in mind.

The system includes all instrumentation necessary to gain adequate exposure to the plantar plate from either the dorsal or plantar approach.  Paragon 28® designed the Paratrooper™ Plantar Plate implant and instruments to allow for simple insertion into tissue and bone through use of an innovative insertion tip, custom needle, and delivery method. Instrumentation is provided to directly address plantar plate deficiency and is included within one kit and is used to facilitate exposure, drilling, and implant placement within a small, limited vascularization environment.  The Paratrooper™ Plantar Plate Repair System was specifically designed to facilitate proper step execution and limit complications intraoperatively.

Paragon 28® is planning for full commercial launch of the Paratrooper™ Plantar Plating System in June 2020.