PliaFX® Pak

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Instructions for Use
Product Specifications

PliaFX®

PliaFX® Pak*
Moldable Demineralized Fibers with Cancellous

*For International Markets Only

PliaFX Pak is a proprietary mix of 100% bone, moldable demineralized cortical fibers with cancellous chips, providing optimized handling, hemostatic1 and osteoconductive2,3 properties. The demineralized fibers interlock with the cancellous chips, allowing the graft to become moldable upon rehydration without the use of a carrier.4

  • Optimized Handling: Fibers interlock with cancellous chips to provide a moldable, intact graft that easily transfers to the surgical site, conforms to the surgical site and resists migration.4

  • Hemostatic: Fibers and cancellous chips facilitate coagulation and stop bleeding.1

  • Osteoconductive: Large surface area and interconnected network of fibers and cancellous chips provides a scaffold that promotes cell attachment and cell spreading.2,3

  • 100% Bone: Demineralized fibers and cancellous chips facilitate natural remodeling during the bone healing process (no human, xenograft or synthetic carriers).

  • New Bone Formation Potential: Fibers demineralized by PAD® technology retain osteoinductive and angiogenic growth factors and thus retain the potential to induce new bone and blood vessel formation in vivo.3,5,6,†

  • Safety: Sterilized using proprietary Allowash XG® technology, providing a sterility assurance level of 10-6 to reduce the risk of disease transmission without compromising the graft’s osteoconductive properties or osteoinductive potential.7,8,9

  • Customizable: Easily mixes with autograft, allograft and/or fluid of surgeon’s choice.4

  • Convenient: Ambient storage and rapid rehydration.4

Clinical Application
  • Orthopedic fracture, fusion, osteotomy and/or other procedures requiring filling of large bone defects to promote healing.
References
  1. Data on file LifeNet Health CC#68143
  2. Murphy MB, Suzuki RK, Sand TT, et al. Short term culture of mesenchymal stem cells with commercial osteoconductive carriers provides unique insights into biocompatibility. J Clin. Med2013; 2,49-66; doi:10.3390/jcm2030049
  3. Data on file LifeNet Health ES-17-111-02
  4. Data on file LifeNet Health ES-21-049
  5. Data on file LifeNet Health ES-17-110
  6. Data on file LifeNet Health TR-19-0446
  7. Data on file LifeNet Health 68-60-037 Sterilization Process Validation
  8. Weintroub S, Reddi AH. Influence of irradiation on the Osteoinductive potential of demineralized bone matrix. Calcif Tissue Int. 1988; 42(4):255-60
  9. Eisenlohr LM. “Allograft Tissue Sterilization Using Allowash XG®.” 2007 BioImplants Brief

† Results in an animal model may not be representative of performance in humans.