Fracture Fixation Plates

Fracture Fixation Plates Made with PEEK-OPTIMA™ Ultra-Reinforced, a carbon fiber (CF) composite

PEEK-OPTIMA Ultra-Reinforced combines the high-performance material properties of PEEK-OPTIMA^TM Natural polymer with the strength imparted by continuous carbon fibers. When manufactured into trauma devices, PEEK-OPTIMA Ultra-Reinforced enables semi-rigid fixation with the potential for improved fatigue and imaging properties over metal. Unlike metals, carbon fiber PEEK (CFR-PEEK) offers the ability to tailor the mechanical properties of the implant without altering the geometry, offering increased design flexibility to meet the device requirements.

Fracture fixation plates composed of PEEK-OPTIMA Ultra-Reinforced have been FDA cleared since 2012, with clinical history dating to at least 2012¹. Selected published and presented studies demonstrate:

• Better union rate compared to metallic plates² 
  • 100% union rate for distal femur fractures fixed with CFR-PEEK versus 76% union rate for stainless steel plates. Fewer revisions versus metallic plates
  • 0% hardware failure for distal femur fractures fixed with CFR-PEEK versus 8% hardware failure for stainless steel plates
• Better reduction compared to metallic plate
  • Restoration of joint line in 98% for distal fibula fractures fixed with CFR-PEEK versus 95% for stainless steel plates³
  • 100% of reductions judged as anatomic or near-anatomic in proximal humerus fractures due to “excellent intra-operative reduction visualization” in fractures without significant deforming forces precluding reduction⁴
• Quicker procedures compared to metallic plates
  • 18% reduction in operative time for tri-mallelolar distal fibula fractures versus stainless steel plates⁵    
• Comparable functional outcome scores to metal plates in distal fibula fractures at 6-24 months³ 
  • In a distal radius case report, at 6 weeks, an elderly patient with multiple risk factors and comorbidities with a distal radius fracture completely healed in a dorsal bone void that was not grafted, and "healing was akin to a much younger person who had been grafted for an almost identical procedure"⁶