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Archaeological evidences clearly indicate that surgical procedure
were performed in several ancient civilizations. Progress in
surgical processes however was slow and mixed liberally with
superstition until the later part of nineteenth century. Scientist
Pasteur's & Liter's antiseptic surgical techniques, developed around
1883 and shortly thereafter Roentgen's discovery of X-rays in 1895
added a new dimension to orthopedic surgery. The great step forward
in technique outstripped the state of material art.
In the beginning of the twentieth century, surgical techniques were
developed for the fixation of the bone fracture with the plate and
screw mechanism. Sherman type bone plate has fabricated from the
best available alloy at that time. i.e. Vanadium Steel.
By the 1920's, use of Vanadium steel Sherman plates became
questionable, because of poor tissue compatibility. At the time
however, no other alloy was available with high strength, good
corrosion resistance properties.
Scientist shortly after developed the introduction of the 18-8
Stainless Steel. Clinical experiments were conducted to utilize the
material for manufacture of surgical implants. This material had
far-superior corrosion resistance to anything that had been
available till that time and hence immediately attracted the
interest of the orthopedic surgeons.
Bone Plate, Screw and other fixation appliances were fabricated and
were being used as surgical implants, although the material
performed better than anything available but has still showed some
susceptibility to attack in the saline environment of the human
body. In 1926, when Scientist Strauss patented the
18-8 SMO Stainless Steel, containing 2-4% molybdenum and a reduced
carbon content of 0.08%. A material was created which promised to
improve resistance to acid and chloride containing environment.
Result of research in 1930's were so encouraging that as a result
the American Orthopedic Committee of the National Research Council
assigned a research project to C.R.Marray and G.C. Fink at desirable
metal or alloy for the internal fixation of the fracture. The study
resulted in recommendation of type 316L stainless steel in 1943.
Subsequent research at several medical centers across the nation
prompted the American College of Surgery at its 1946 meeting to
endorse type 316L stainless steel for use in surgical implants.
During the 1960's, the ASTM F-4 Sub-committee was formed to
standardize materials used in surgical implants. Manufacturing
currently available of high quality stainless steel are now
recommended for this application. The desirable properties of low
carbon and vacuum of electrolyte remitted material have been
published. The table below summarizes the chemical requirement of
these ASTM standards. Note that the alloy chemistry is identical to
the AISI material Table.
Analysis
of StainLess Steel 316L :
Chemical composition of low-Carbon Stainless Steel in manufacturing
of Surgical Implants.
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Carbon |
0.03 max |
Chromium |
17.00-20.00 |
|
Manganese |
3.00 max |
Nickel |
10.00-14.00 |
|
Phosphorous |
0.03 max |
Molybdenum |
2.00-4.00 |
|
Sulfur |
0.03 max |
Iron |
Balance |
|
Silicon |
0.75 max |
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