Innovasis' 'PEEK Box' System as Vertebral Body Replacement (VBR), Submitted to the USFDA for Clearance

Filed in archive Diagnostics , Treatment on August 6, 2006

Innovasis, the Utah-based spinal implant company has submitted its "PEEK Box" System to the USFDA for 510(k) clearance.

Manufactured from PolyEtherEtherKetone (PEEK) with Tantalum ELI markers, the "PEEK Box" system will be used as a Vertebral Replacement within the spine. PolyEtherEtherKetone (PEEK) is a material with an elasticity module (GPA) that is the closest to Cancellous Bone compared to Cortical Bone, Titanium or Stainless Steel implants.

The PEEK box system includes the following features and benefits:
•various shapes
•proud angled tooth design on superior and inferior surfaces to resist migration
•bullet-shaped tip to assist in distraction
•parallel and lordotic-shaped with large central apertures for placement of bone graft

This "PEEK Box" System from Innovasis had previously received 510(k) clearance as a Cement Restrictor but has recently been re-submitted to the FDA for clearance as a VBR (Vertebral Body Replacement) for Spinal indications.

Spinal implants, such as the "PEEK Box" system, are aimed at restoring mechanical and neurological function by readjusting vertebral positioning until bone fusion occurs.

Like its "PEEK Box" system, Innovasis offers spinal product implants and instruments that address major pathologies and focus areas of traditional spinal surgery, including deformities, degenerative conditions; trauma and tumors, all of which can result in severe back pain and sometimes paralysis.

Source: PR Newswire