Bridge

FUSION without boundaries.

invibio spine device technology

PEEK-OPTIMA Spinal Rod Components

FDA reclassifies semi-rigid spinal stabilization systems providing new possibilities for treating patients.

The US Food and Drug Administration (FDA) has recently reclassified semi-rigid spinal stabilization systems from Class III to Class II * offering a regulatory pathway to 510(k) clearance in the United States for innovative devices using PEEK-OPTIMA™ polymer based rods.  Substantial evidence was presented in reaching this conclusion, including data from over 51,000 PEEK rod implantations.

The FDA decision supports the safety of semi-rigid systems and provides greater options for surgeons who prefer more flexibility than traditional rigid pedicle screw systems to achieve fusion.

To learn more about the final ruling, “Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems”  click here

 

* The US Food and Drug Administration (FDA) renamed dynamic stabilization systems as "semi-rigid systems," and defined them as a sub-type of pedicle screw systems, now referenced as "thoracolumbosacral pedicle screw systems"


Semi-rigid constructs bridge the treatment gap.

Invibio PEEK-OPTIMA Spinal Rod components offer a semi-rigid posterior fixation solution that bridges the gap between stiff all-metal constructs and dynamic treatment options. Constructs built with PEEK-OPTIMA spinal rods have the same level of stability as those built with Titanium rods, with the added benefit of a lower stiffness and radiolucency.

Patients may benefit from:
  • Improved load sharing to encourage fusion. 1-3
  • More physiologic loading at adjacent levels, which may decelerate degeneration. 4-5
  • Reduced stress at the bone-to-screw interface, which may prevent screw pull-out, especially in patients with questionable bone quality. 4-5

Let your colleagues know about PEEK-OPTIMA Spinal Rod Components.

Click here to forward this to a colleague.


Invibio - the worldwide innovator in implantable PEEK biomaterials.

Invibio is a proven partner to medical device manufacturers and a leading provider of biomaterial solutions. Our revolutionary polymers, unsurpassed manufacturing support, and deep device knowledge have enabled device companies around the world to bring innovations to market for over 15 years.

Contact Us


References