Bioretec received FDA 510(k) clearance to market the RemeOs trauma screw system in the U.S. The device is reportedly the first and only bioresorbable metal implant cleared for use.
The product range and indication align with a clinical trial conducted in the ankle. Bioretec will launch RemeOs trauma screws in the U.S. in collaboration with hospitals and clinical professionals that specialize in ankle fractures.
Bioretec has developed the RemeOs line based on a magnesium alloy and hybrid composite. The implants are resorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant.
“This FDA market approval is the most important milestone in our company’s history to date,” comments Timo Lehtonen, CEO of Bioretec. “The U.S. has the world’s largest market for orthopedic implants. For the first time, that market is now offered a bioresorbable alternative to be used instead of titanium and steel implants. We are confident that RemeOs trauma screw is the best option for a large share of patients considering the care and clinical outcome and from a health economics viewpoint thanks to making an additional removal operation unnecessary. We are also excited about this approval opening a less burdensome regulatory pathway for future RemeOs™ product lines covering a wide array of indications.”
Bioretec received FDA 510(k) clearance to market the RemeOs trauma screw system in the U.S. The device is reportedly the first and only bioresorbable metal implant cleared for use.
The product range and indication align with a clinical trial conducted in the ankle. Bioretec will launch RemeOs trauma screws in the U.S. in collaboration with...
Bioretec received FDA 510(k) clearance to market the RemeOs trauma screw system in the U.S. The device is reportedly the first and only bioresorbable metal implant cleared for use.
The product range and indication align with a clinical trial conducted in the ankle. Bioretec will launch RemeOs trauma screws in the U.S. in collaboration with hospitals and clinical professionals that specialize in ankle fractures.
Bioretec has developed the RemeOs line based on a magnesium alloy and hybrid composite. The implants are resorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant.
“This FDA market approval is the most important milestone in our company’s history to date,” comments Timo Lehtonen, CEO of Bioretec. “The U.S. has the world’s largest market for orthopedic implants. For the first time, that market is now offered a bioresorbable alternative to be used instead of titanium and steel implants. We are confident that RemeOs trauma screw is the best option for a large share of patients considering the care and clinical outcome and from a health economics viewpoint thanks to making an additional removal operation unnecessary. We are also excited about this approval opening a less burdensome regulatory pathway for future RemeOs™ product lines covering a wide array of indications.”
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