Biotek means the responsiveness and innovation of a small company, with the resources and market presence of a large company. BIOTEK offers a highly specialized and exclusive product range which extends through sports medicine products; cervical, thoracic, lumbar spine products; shoulder, and elbow hip joint replacement prosthesis; trauma products; all kinds of instrumentation for arthroscopic and orthopedic procedures.
BIOTEK implants are made of stainless steel, pure titanium, titanium alloys and PEEK. The materials are tested for biocompatibility and safety according to EN ISO 10993 and EN ISO 14971. The Chromium-Nickel-Molybdenum alloyed austenitic stainless steel used for BIOTEK implants complies with the international standards ISO 5832-1 and ASTM F138/ASTM F139. The chemical composition, mechanical properties, and the purity of the microstructure meet the requirements specified by these standards.
Titanium is used in different variations according to the product:
· As softer and more malleable pure titanium TiCP (ISO 5832-2/ASTM F67);
· As harder titanium alloy Ti-6Al-4V ELI (ISO 5832-3/ASTM F136)
All PEEK (polyetheretherketone) polymer material used to manufacture our products meets ASTM F2026 specifications and is produced and extensively tested to meet ISO-10993 requirements. PEEK is an extraordinary high-performance polymer that brings together properties like extreme durability, temperature resistance, absence of corrosion, and light weight making it ideally suited for some arthroscopy and spine implants. Additionally, PEEK stands out for good abrasion resistance and a low friction coefficient,
BIOTEK buys the implant raw material from reputed international suppliers. Appropriate laboratory material acceptance tests are carried out according to statistical criteria. The material is released for implant production only if its chemical composition, microstructure, purity, mechanical strength and surface quality comply with international standards. The 'material grade' quality stands out for highest purity, complete lot traceability and constancy in manufacturing and processing.
The quality of the implants is constantly proved and ensured by various in vitro and in vivo studies. Precision production techniques; surface treatment; exact individual manufacturing and final inspection ensure the consistency in high quality standards of BIOTEK implants. The producer meets the strict regulations of EU directive (Medical Device Directive 93/42/EEC) and US-FDA requirements. BIOTEK maintains a quality management system which is regularly certified in accordance with international standards ISO 9001:2008; ISO 13485:2003; ISO 10002:2004 and MDD 93/42/EEC.
Unique Orthopedic Savoir-faire:
BIOTEK owes its rapid growth and international reach to its thorough expertise of the orthopaedics market and technologies. It employs highly experienced, innovation-driven professionals and engineers and manufactures more than 100,000 orthopedic instruments and implants a year.
BIOTEK operates state-of-the-art production facilities located in India. Our facilities currently produce several thousand different types of instruments and implants for the most demanding customers in the global orthopedic, sports medicine, spinal and trauma markets.
With over a decade of successful medical device product experience behind us, BIOTEK has learned to identify, adopt and master the technologies that can make a difference to our customers in terms of performance, quality, reproducibility, deadlines and production costs. We are now one of the uncontested leaders in India in the production of complex instruments and advanced implants.
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