In the field of arthroplasty, roughly 500,000 prosthetic knees and hips are implanted annually in the U.S. This number is expected to increase six fold as """"""""baby boomers"""""""" age. Tribological assessment of all materials available for the fabrication of hip implants indicates that ball components fabricated of partially stabilized (toughened) tetragonal zirconia (zirconia doped with 3 mol % yttria, 3YSZ) offer superior wear against polyethylene cups. These in turn offer superior life expectancy for the prosthetic joint in vivo compared with every other material examined. The ceramic hip joint market in the U.S. has always been dominated by European manufacturers. Recently, there have been sufficient failures of European manufactured hip components that the FDA forced a recall of all zirconia-based joints with no replacements forthcoming. Biopro, a Port Huron, MI company co-founded by Dr. Louis Serafin was the only FDA certified U.S. supplier of toughened zirconia hip joints in the U.S. but no longer produces them. Tal Materials has learned to produce large quantities of very high quality nanosized 3YSZ powders using controlled energetic precursor technology (CONCEPT). These nanopowders offer the potential to produce toughened zirconia hip joints with even better properties than the original produced materials. Tal has also learned to consolidate dense 3YSZ monoliths from this nanopowder that offer good-to-excellent purity (chemical and phase), high densities with nanostructured grains, and mechanical properties. These materials are very close to satisfying the ASTM standard F1873 that must be met before any 3YSZ prosthetic component is acceptable to the FDA. Tal Materials has teamed with Dr. Louis Serafin currently CEO of Signal Medical Co. to become the only U.S. supplier of ceramic hip and eventually knee femoral components. As a first step in this relationship TAL proposes under this Phase I to establish protocols leading to a high degree of reproducibility in YSZ ceramics with mechanical properties superior to ASTM F1873. Tal will make the hips and Dr. Serafin will help us qualify with the FDA and also help market these components.
