Non-Sterile Bone Fixation Element

The commercial models that make up the Non-Sterile Bone Fixation Element family are defined as fixation devices, classified as implantable, long-term surgically invasive medical devices.

The Non-Sterile Bone Fixation Element is also considered a partially threaded transcutaneous pin, referred to as an anchoring element for the external fixation system, also known as a smooth pin, threaded pin, Schanz pin, etc.

The mechanism of action of the pin in the bone is to: stabilize, restrict or control the movement of bone fragments, assist in fracture reduction, correct or control alignment, provide stability to the affected region, and provide safe placement in relation to adjacent structures.

The typical clinical applications of the pins are: fracture treatment, stabilization, lengthening and bone transport. They can be used in medium and long bones of the extremities of the human body.

The design and use of these bone fixation medical devices are based on the understanding of bone healing and of the loads and forces to which the implant is subjected. During the insertion process, the pins are subjected to torsional forces and to bending loads due to the resistance of the assembly around axes parallel to the pins.

The threaded part of the pin is implanted in the patient's bone, while the smooth part is attached to the External Fixators (ancillary components).

The Pin was developed to withstand the most critical loads, namely bending and torsion. In this way, it assists in structural stability and also in the transmission or relief of mechanical loads on the affected bones.

The pins were designed for application in the different structures of the medium and long bones of the extremities of the human body. Their cylindrical thread diameters range from Ø 4.0 to 4.5 mm, and the tapered threads range between Ø 2.5-2.0, 3.0-2.5, 3.5-3.0, 4.0-3.3, 4.5-3.5, 5.0-4.0, 6.0-5.0 and 6.0-5.6 mm.

The Non-Sterile Bone Fixation Element is indicated for the treatment of fracture, stabilization, stretching and bone transport, and can be used in medium and long bones of the extremities of the human body.

Stainless Steel ASTM F138