35 years shaping the future of healing. Since 1990, TEKNIMED has continuously strengthened its industrial and scientific excellence: enhanced quality requirements (ISO 13485, process validations, sterility), expanded capacities, multiplication of cleanrooms, and strict alignment with evolving regulations (MDR, FDA 21 CFR Part 820, MDSAP).
This methodical progression has resulted in hundreds of product registrations, regular audits, and major regulatory milestones. A tangible guarantees of reliability and clinical performance.
Today, TEKNIMED is a trusted partner for leading medical device companies, delivering reliable OEM and Private Label biomaterials with fast time-to-market and long-term collaboration.
• A former military pilot and entrepreneur with close ties to the medical field, Alain Léonard launched Teknimed’s activities by developing and trading biomaterials.
• During his career in medical field, he developed also within Teknimed in partnership with well known surgeons innovative patent like Equinoxe shoulder prosthesis sold to Exactech, Spinejack spinal system sold to Vexim.
This reinforce Teknimed’s commitment to quality and expanding its regulatory reach and development of the biomaterials business.
Both cements and synthetic bone substitutes were developed and manufactured in-house.
Bone cement for arthroplasty with and without antibiotics.
• Opening of a new facility in Toulouse dedicated to polymer injection.
• Installation of an injection molding in clean room ISO 7 for the manufacturing bio absorbable interference screw in PLA/TCP.
• Achievement of ISO 13485 and ISO 9001 certifications, FDA 21 CFR Part 820 compliance, and first 510(k) clearance.
One of the first bone cement with antibiotic was registered.
• The first resorbable cement restrictor.
• Synthetic ceramics with hydroxyapatite & tricalcium phosphate.
• The first calcium phosphate featuring hydroxyapatite nanoparticles.
• The first patented spinal bone cement featuring hydroxyapatite.
• Acceleration of industrial expansion and quality strategy.
• First U.S. spinal cement agreement with 510(k) clearance for F20®.
Medium & high spinal bone cements.
Formal entry into the MDSAP program with BSI, advancing multi-regulatory convergence.
100% of products submitted to BSI for MDR approval. All range of products kept for transition process.
100% of the Teknimed product range certified under MDR (EU) 2017/745.
A milestone year with two major achievements:
• More than 1200 registrations worldwide.
• Acquisition of a 3rd site in Toulouse, Teknimed has now 8300 m2 land plot.
800 m² of storage capacity and 300 m² of office space.
