Hogan Lovells counsels Bioretec in first ever De Novo grant for bioresorbable metal trauma screw
Global law firm Hogan Lovells advised Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, in securing Food and Drug Administration (FDA) De Novo premarket authorization for Bioretec’s RemeOs™ trauma screw in the U.S. The screw is the first and currently only bioresorbable metal implant approved by the FDA. Read more about the approval here.
The FDA premarket authorization, which was granted 30 March, was based on clinical trials conducted in the ankle. Bioretec will launch the RemeOs™ trauma screws in the U.S. in collaboration with clinical professionals specialized in ankle fractures, which are one of the most frequently occurring fracture types among the adult patient population.
The RemeOs™ trauma screw had previously been granted the FDA’s Breakthrough Device Designation for use in skeletally mature adults, as bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants.
The Hogan Lovells team for Bioretec included Medical Device regulatory partners Jonathan Kahan and Randy Prebula, in addition to Director of Regulatory Affairs Jemin Jay Dedania and Senior Director of Regulatory Strategy Michael Kasser, all based in Washington, D.C.
For more information from FDA, please see here.
Press contacts
Press contacts
