U.S. implant manufacturers have recently received FDA’s clearance for products manufactured with Arcam’s EBM® technology. With the FDA clearance the companies are allowed to market their products on the important U.S. market.
The U.S. market for orthopaedic implants represents about half of the world-wide implant market. Up to now U.S. sales of orthopaedic products manufactured with Arcam’s EBM technology have been limited to patient-specific implants, which do not require clearance. Arcam already has systems installed for orthopaedic applications at four U.S. companies. These recent FDA clearances open up a market with a large potential, and are a further confirmation that implants produced with the Arcam technology fulfil the high standards and demands in the orthopaedic implant industry.
“Our customers in Europe have, since 2007, produced and implanted more than 10.000 CE-certified advanced orthopaedic implants with our technology. These recent FDA approvals are an important step towards a broad acceptance of Arcam’s EBM technology for implant manufacturing on the large and important U.S. market”, says Magnus René, CEO of Arcam.
For further information:
Magnus René, CEO, Arcam, tel. +46 31 710 32 00
Cell: +46 702 79 89 99, E-mail: magnus [dot] rene [at] arcam [dot] com