INTRAMEDULLARY NAILS

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

PEEK-OPTIMA Ultra-Reinforced combines the high-performance material properties of PEEK-OPTIMATM 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.

Intramedullary nails composed of PEEK-OPTIMA Ultra-Reinforced have been FDA cleared since 20101, with clinical history dating to at least 20092. Selected published and presented studies demonstrate:

  • Greater percent of femoral nail cases healed at 6-week time period compared to reported rates of metal3
  • Pain free ambulation without assistive devices in 4-7 weeks4 in patients with tibia and fibula nails
  • Pain relief in patients' pathologic fractures of the humerus, tibia, and fibula4-8   
  • Less MRI and CT artifact than metal, allowing greater visualization near the implant5

References

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.

3.  Ziran BH, Mansour J, Jahangir AA, Min W. Efficacy of Carbon Fiber-Reinforced PEEK Femoral Nail Preliminary Results. Poster #68. Presented at OTA 2017.

4.   Allison DC, Menendez LR. Carbon fiber fixation in oncologic bone surgery. Presented at MSTS Meeting 2013. Carbon Fiber Intramedullary 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.

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.

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, Caforio M, Groppi G, Vallisa D, Cavanna L. The carbon fiber intramedullary nail in pathological humeral shaft fractures: two case reports. JJ Ortho Rheum. 2015, 1(2): 008.

Learn about other Trauma Applications

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