FBC Device Receives EU Approval for Spinal Implant

Danish medical device company FBC Device has received ISO 13485 certification and the CE mark for its first spinal fusion implant, the Statur-L.

“We are very pleased to have achieved both ISO 13485 and CE mark,” FBC founder/CEO Prof. Finn Bjarke Christensen said. “Attaining CE mark on our first product line allows us to start clinical activity at leading European spine centers to document the benefits for chronic low back pain patients, surgeons and hospitals.”

The Statur-L is a hybrid of fusion and non-fusion technology, taking the best from both surgery approaches to potentially benefit the patient, the surgeon, the hospital and the medical device company. Surgeons gain a better way to address the loss of spinal curvature common in patients undergoing fusion, clinicians contend. According to research, the loss of curvature is linked to back pain and restoration of the curvature is linked to better results for patients undergoing fusion surgery. In addition, the Statur-L design reduces the number of implants needed, benefiting the hospital and the medical device company, FBC claims.

Recent data support the Statur-L’s efficacy. Specifically, research has concluded the Statur-L reduces relative movement between the implant and the spinal bone, helping ensure the surgeon’s restoration of curvature during surgery is not lost following surgery. Leading spine biomechanics expert, Prof. Hans-Joachim Wilke from Ulm University, who conducted the research said the Statur-L “appears capable” of solving biomechanical issues associated with existing fusion implants.

FBC Device is a knowledge-based company, focusing on intellectual property, product research and development, and clinical documentation to commercialize orthopedic implants.