As a worldwide manufacturer of spinal hardware for surgery, BK MEDITECH USA is committed to fabricating quality implants and seeking those same high standards from the suppliers of our raw materials to demonstrate our commitment to patient safety. We have sourced our manufacturing materials from only the most reputable USA based suppliers for PEEK, titanium, and tantalum, and our implants are made with steady certainty so that our patients and surgeons can be confident and secure knowing we are utilizing the highest quality materials within the strictest benchmarked standards. BK Meditech USA’s curated suppliers hold ISO 9001, ISO 13485, and 93/42/EEC, and the Certificate of European Conformity (CE) are qualified with the standards established ranging from material procurement to design development and automated production process systematizing an unrivaled quality assurance process that exceeds many global standards.
OUR PEEK PRODUCTS
BK MEDITECH USA fabricates PEEK implants with materials from lnvibio, based within the USA, who over the many years, has proven to be a leader of biomaterial solutions. For over twenty years, lnvibio has utilized its progressive biomaterials, superb fabricating, and profound experience to aid medical device companies around the globe in bringing progressive technologies to healthcare, at a rapid pace. lnvibio possesses an unrivaled depth of knowledge and vast experience in the design, manufacturing, and commercialization of medical devices containing PEEK-based polymers. lnvibio invites the opportunity to work directly with their customers to address neglected clinical needs by creating next-generation implant technologies composed of PEEK-OPTIMA polymers. Patient’s awareness and increased regulations and criticisms have made it more challenging for inventive modern implants, but by collaborating with lnvibio, the leader in PEEK processing, BK Meditech USA can optimize new product design and development programs to manufacture implants that positively affect patient outcomes.
OUR TITANIUM PRODUCTS
BK MEDITECH USA fabricates its titanium technologies with materials from another USA based company, Dynamet. Dynamet is a worldwide provider of quality titanium products in a vast array of options including wire, fine wire, precise shapes, coil, strip, and bar. A division of the Carpenter Technology Organization, Dynamet sets the standard for high-grade medical titanium amalgam materials. Inside the medical implant realm, titanium is the metal of choice due to its favorable biomedical characteristics that include idleness to bodily liquids and fluids, as well as an excellent strength-to-weight proportion, molecular breakdown resistance, and predominant osseointegration capabilities. Our high-quality Dynamet titanium amalgams are utilized by the world’s best restorative implant manufacturers for applications that incorporate joint substitution (knee, hip, bear, etc.), dental inserts, ORIF surgery (screws, plates, bars, and pins), combination equipment (pedicle screws and spinal poles), and vascular methods (stents, coil impediment, PDA closure, etc.). Also, the alloy’s non-ferromagnetic properties permit patients with titanium inserts to be examined with MRI, NMRI, and MRT restorative imaging/ radiology
TANTALUM MARKER INSERTS
BK MEDITECH USA utilizes the quality tantalum of X-medics, also supplied to five of the ten biggest spinal implant companies globally. BK MEDITECH USA has chosen X-medics due to their complex biocompatibility testing, cytoxicity reports, the cleaning and passivation processes, and the utilization of autonomous ISO 17025 authorize research facilities for material testing of tantalum wire as well as all materials utilized in manufacturing tantalum globules/ balls/ spheres. BK MEDITECH USA uses this leading supplier of medical-grade tantalum beads, tantalum balls, tantalum spheres, and tantalum wire within medical-grade tantalum components.
The surgical grade and medical grade tantalum utilized in medical devices are specified in a number of standards such as; ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400), ISO 13782: Implants for surgery ·Metallic materials· Unalloyed tantalum for surgical implant applications, and BS 7252-13: Implants for surgery ·Metallic materials – Unalloyed tantalum for surgical implant applications. These standards specify the chemical, mechanical, and metallurgical requirements for unalloyed tantalum used in orthopedic surgery or in the manufacture of surgical implants.