Bioretec Gains CE Mark for Activa IM-Nail, Activa Screw

By Julie A. Vetalice

Bioretec Gains CE Mark for Activa IM-Nail, Activa Screw

Bioretec was granted CE Mark approval for two bioresorbable devices, the Activa IM-Nail™ and the ActivaScrew™ Interference TCP screw.

Activa IM-Nail is reportedly the first fully-bioabsorbable option for pediatric forearm intramedullary nailing. The device offers an economical solution for hospitals, as it obviates the need for implant removal.

Activa IM-Nail is made of self-reinforced PLGA with an osteoconductive tricalcium-phosphate marker in the tip, allowing faster mini-invasive navigation with enhanced implant visibility in the x-ray. Shorter versions of the device are suitable for intramedullary distal radius and ulna fracture fixations.

The company also received approval under the CE Mark for ActivaScrew™ Interference TCP for ligament fixation, reportedly the smallest biocomposite interference screw on the market. ActivaScrew uses Bioretec´s Self-Locking SL™ technology that allows the implant to expand in diameter by 1% to 2% in the body, adding to secure fixation.

Bioretec products are sold in over 35 countries worldwide. The company is developing materials and product lines for high load-bearing clinical applications based on new materials and composites. A next-generation bioresorbable metal, RemeOs™, is in clinical testing with promising interim results. RemeOs is based on naturally-occurring metals in the human body, magnesium, zinc and calcium.

Product Labels: Arthroscopy Equipment

Tags: CE Mark, Regulatory