Fracture Fixation Plates

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

With more than fifteen years of clinical history, PEEK-OPTIMA Natural polymer, is the first medical-grade PEEK used in spinal fusion surgeries. PEEK is currently the most popular biomaterial for interbody fusion, accounting for 73% of all devices used in 2013.1

PEEK-OPTIMA Ultra-Reinforced combines the high performance material properties of PEEK-OPTIMA Natural polymer with the strength imparted by continuous carbon fibers. When manufactured into trauma devices, PEEK-OPTIMA Ultra-Reinforced enables semi-rigid fixation with improved fatigue and imaging properties over metal. Unlike metals, the carbon fiber 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 20123. Selected published and presented studies demonstrate:

  • Better union rate vs. metallic plates:
    • 100% union rate for distal femur fractures fixed with CFR-PEEK vs. 76% union rate for stainless steel plates Fewer revisions: vs. metallic plates
    • 0% hardware failure for distal femur fractures fixed with CFR-PEEK vs. 8% hardware failure for stainless steel plates4
  • Better reduction vs. metallic plates
    • Restoration of joint line in 98% for distal fibula fractures fixed with CFR-PEEK vs. 95% for stainless steel plates5
    • 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 reduction6
  • Quicker procedures vs. metallic plates
    • 18% reduction in operative time for tri-mallelolar distal fibula fractures vs. stainless steel plate3
  • Comparable functional outcome scores to metal plates in distal fibula fractures at 6-24 months5
    • 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”7

References

  1. IMS Health, SpineMarket 2016, Minneapolis, MN.
  2. K102597 – Piccolo Composite Plating System submitted by N.M.B Medical Applications, Ltd.
  3. Caforio M, Perugia D, Colombo M, Calori GM, Maniscalco P. Preliminary experience with Piccolo Composite™, a radiolucent distal fibula plate, in ankle fractures. Injury. 2014 Dec;45 Suppl 6:S36-S38. Doi: 10.1016/j.injury.2014.10.020. Operative time data included in earlier presentation by Pietro Maniscalco at 2014 AOFAS Meeting in Chicago, “Preliminary Experience with Carbofix – Radiolucent Distal Fibula Plate In Ankle Fractures
  4. Carbofix OTA Study
  5. Guzzini M, Lanzetti RM, Lupariello D, Morelli F, Princi G, Perugia D, Ferretti A. Comparison between carbon-peek plate and conventional stainless steel plate in ankle fractures. A prospective study of two years follow up. Injury. 2017 Jun;48960:1249-1252.
  6. Hak DJ, et al. Seeing is believing: treatment of proximal humerus fractures using a novel radiolucent implant and its effect on reduction accuracy, healing rate, and functional outcome. Paper #482. Presented at EFFORT 2014 meeting. 
  7. Rives AW. Case Series on Invibio YouTube Channel

Learn about other Trauma Applications

Explore how our proven carbon fiber (CF) composite material, PEEK-OPTIMA™ Ultra-Reinforced can offer potential clinical advantages

The materials on this site are intended for Heath Care Professionals and industry users only. If you are a patient, click here, otherwise, click continue.