Shark Screw® allograft - Shark Screw®

Biointelligent

Shark Screw® allograft

Every year, about 40,000 osteosyntheses are performed in Austria. Hallux valgus, as well as rigidus, fractures, arthroses and pseudarthroses, are the most common indications. The Shark Screw® graft is the first allogenic bone screw, used for osteosynthesis in the field of hand, elbow, knee, and foot surgery.

The Shark Screw® combines the advantages of a fine-threaded screw with that of a human bone matrix, enabling bone fragments to be securely and stably connected without the use of inorganic or bioresorbable materials. Due to its natural material properties, the Shark Screw® has an osteoconductive effect, becomes vascularized after six weeks and is infiltrated by the body’s bone cells. After about one year, the graft will no longer be visible on X-ray because the density of the graft will be equal to the density of the surrounding bone tissue.

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Electron microscope images show the natural structure of the Shark Screw®. Havers canals support the recepient bone in connecting to the transplant. (TU Graz FELMI Prof. DI. Dr. Plank)

Properties & Biomechanics

For the development of the innovative Shark Screw® graft, surgebright collaborated with the Institute of Biomechanics and the Institute of Electron Microscopy and Fine Structure Research at the University of Technology in Graz. An important goal was to develop the unique design of the graft in order to achieve maximum resilience and thus highest patient safety.

Biointelligent transformation

Intact Havers canals serve as a key structure for the bone remodeling processes. The avital Shark Screw® transplants become integrated completely into the bearing bone and are converted into patients bone by the physiological bone metabolism. Even possible protrusions of the screw are naturally degraded and adjusted to the original, ideal bone surface.

biological material

The body recognizes and accepts the natural, allogenic material of the bone screws. No repulsive or foreign body reactions that may occur for conventional care methods are known. Postoperatively, X-ray and MRI diagnostics are possible without obstruction.

Reduction of complications

No immunological reactions are known, the Shark Screw® transplants are free of toxic or mutagenic side effects. Due to its biological origin, excellent compatibility is provided. Postoperative pain levels are remarkably low, due to the shortening of the screw to bone level and the very high compatibility of the material.

Elimination of second operations

The hardware removal surgery is a disadvantage of conventional osteosynthesis materials with all the resulting complications and risks for the patient during and after the second intervention. Surgery with the Shark Screw® omits this procedure, which helps to relieve our healthcare systems. Due to the compatibility of the material, faster regeneration of the patient and reduced pain levels are common and lead to a reduction of sick leaves.

High mechanical stability

The cortical bone material resists high loads. Together with the University of Technology in Graz, Shark Screws® of different diameters were developed according to the requirements and field of application. Additionally, the fine thread with several threads per millimeter leads to an ideal self-locking mechanism.

sterilization

The Shark Screw® grafts are sterilized by a peracetic acid ethanol process. This results in a validated sterilization and inactivation procedure without gamma irradiation.

Field of application for the Shark Screw®

Indications

Economical advantages

with the Shark Screw® ...

reduce costs

By using the Shark Screw®, hospitals may offer a bio-intelligent solution to the patients and increase their cost-effectiveness which is scientifically proven by a study of the IPF Vienna¹.

Minimize sterilization effort

The small instrument set saves space and costs for sterilization. The sterilization of unused grafts is no longer required. Low storage costs due to minimal space requirements.

Relieve healthcare systems

The reduction of complications and pain, as well as the elimination of the second operation for hardware removal results in shorter sick leaves for the patient. Our healthcare system benefits from a reduced number of operations necessary and fewer and less expensive sick leaves.

¹ Evelyn Walter, Karin Schalle & Marco Voit. (2016). Cost-Effectiveness of a bone transplant fixation “SHARK SCREW” transplant compared to metal devices in osteosynthesis in Austria. ISPOR 19th Annual European Congress. Vienna: IPF Institute for Pharmaeconomic Research

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