INTRAMEDULLARY NAILS

Fracture Fixation Nails 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.

Intramedullary nails composed of PEEK-OPTIMA Ultra-Reinforced have been FDA cleared since 20111, with clinical history dating to at least 20092. Selected published and presented studies demonstrate

  • Potential better early healing rate:
    • Earlier healing at 6 week s for a distal femur nail compared to metallic constructs a
  • Ease of visualization with undisturbed
    • 0% hardware failure for distal femur fractures fixed with CFR-PEEK vs. 8% hardware failure for stainless steel plates3
  • Pain free ambulation without assistive devices in 4-7 weeks4 in patients with tibia and fibula nails.
  • Pain relief in pain relief for patients pathologic fractures of the humerus, tibia, and fibula4,5,6,7
  • Less MR and CT artifact than metal, allowing greater visualization near the implant,5

Reference

  1. K091425 – Quantum M Composite Nailing System submitted by N.M.B Medical Applications, Ltd.
  2. Rangger C, Özgün C. Implantation of Carbon-Fibers-PEEK intramedullary humeral nail for trauma and pathological fracture fixation—a multi-center, international retrospective accumulated Experience. Presented at OTA 2013, Abstract #4063. https://media.wix.com/ugd/cd37de_6180ce2b6640413aa5a4ec023c7b586b.pdf 
  3. Carbofix OTA Study
  4. Allison DC, Menendez LR. Carbon fiber fixation in oncologic bone surgery. Presented at MSTS Meeting 2013. https://media.wix.com/ugd/cd37de_06f4bfa853924358bd5b8f06d6423452.pdf Accessed May 18, 2017 and Carbon Fiber Intremedullary Nail Fixation in Troublesome Long Bone Fractures and Nonunions in Cedars-Sinai Advances in Orthopaedics newsletter, Spring 2014.
  5. Zimel MN, Hwang S, Riedel ER Healy JH. Carbon fiber intramedullary nails reduce artifact in postoperative advanced imaging. Skeletal Radiol. 2015 Sep;44(9):1317-25. Doi:10.1007/s00256-015-2158-9
  6. Zoccali C, Soriani A, Rossi B, Salducca N, Biagini R. The Carbofix™ “Piccolo Proximal femur nail”: a new perspective for treating proximal femur lesion. A technique report. J Orthop. 2016 Jul;13(4):343-6. Doi: 10.1016/j.jor.2016.07.001.
  7. Collis PN, Clegg TE, Seligson D. The invisible nail: a technique report of treatment of a pathological humerus fracture with a radiolucent intramedullary nail. Injury. 2011 Apr;42(4):424-6.
  8. Maniscalco P, Marco C, Guilia G, Daniele V, Luigi C. The carbon fiber intramedullary nail in pathological humeral shaft fractures: two case reports. Jacobs Journalof Orthopedics and Rheumatology. http://www.jacobspublishers.com/images/Orthopedics/J_J_Ortho_Rheum_1_2_008.pdf Accessed May 18, 2017

Learn about other Trauma Applications

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

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