The RODD device, class IIb medical device, is an interspinous spacer which is intended to be implanted
between two spinous processes via posterior approach in order stabilize the lumbar spine while
restoring the interspinous height and physiological movement, reducing the chance to develop
adjacent level disease. Interspinous distraction and stabilization aims to reduce patient’s pain and
disability.
This surgery, performed by orthopedic surgeons or neurosurgeons on skeletally mature patients, is
conducted in the lumbar region of the spine. This specific implants has been designed, developed and
distributed by Novaspine this treated area. Medical indications, contraindications, general adverse
events, lifetime and safety measures are gathered in the IFU provided with the RODD device.
Performance claims focuses on pain reduction and disability reduction, while safety claims concern
screw breakage or migration rates.
All the RODD products have been CE marked and implanted since 2006.