Implanet secures FDA 510(k) clearance and CE mark for Jazz Claw implant

23 May 2016 (Last Updated May 23rd, 2016 18:30)

France-based medical technology Implanet has secured the US Food and Drug Administration (FDA) 510(k) clearance and CE mark in Europe for its new Jazz Claw implant.

France-based medical technology Implanet has secured US Food and Drug Administration (FDA) 510(k) clearance and CE mark in Europe for its new Jazz Claw implant.

Jazz Claw is a hybrid implant offering autostable posterior fixation which replaces the existing hook-and-screw fixation systems and treats complex degenerative pathologies in adults (kyphosis).

Kyphosis is characterised by a curve in the spine which is 45 degrees more than a normal curvature, causing the top of the back to appear more rounded than normal.

"Jazz Claw is a new hybrid solution that provides ease of use, versatility and the power of sublaminar band reduction in a high-demand location."

More prevalent in adults, it can cause back pain, stiffness, tenderness of the spine and cause tiredness.

Jazz Claw adds to Implanet's Jazz Band platform dedicated to degenerative pathologies, which represent the largest spine surgery market segment.

Additionally, its autostable characteristics help in the treatment of adolescent scoliosis with hybrid fixation.

Implanet product development and manufacturing director Régis Le Couedic said: "Jazz Claw is Implanet's response to the complex issue of securing the top of constructs in adolescent scoliosis and adult degenerative deformities.

"This biomechanically challenging area was traditionally treated with pedicle screws or hooks, with inherent drawbacks that the Jazz Claw eliminates.

"The result of a collaboration with prominent surgical teams, Jazz Claw is a new hybrid solution that provides ease of use, versatility and the power of sublaminar band reduction in a high-demand location."