Tissue Sterilization

Tissue Sterilization

RTI Surgical was founded with a specific purpose to make tissue safe. We have led the way in safety for tissue-based implants for more than 25 years, always keeping the patient and donor in mind. This is evident by our redundant safeguards that go above and beyond industry norms and standards. We are proud of our track record, having distributed more than 11 million tissue-based implants processed through our proprietary sterilization processes with zero confirmed incidence of implant-associated infection.

Through our focused approach to innovation, we are continuously raising the bar of science and safety for tissue-based implants. We have introduced several industry “firsts,” including being the first company to offer precision-tooled bone implants and assembled technology and the first to introduce proprietary, tissue-specific validated sterilization processes that address the risk of donor-to-recipient disease transmission.

RTI offers two types of tissue-based implants:

  • Allograft: An allograft implant is tissue surgically transplanted from one person to another. Depending on the type of transplant, surgical application and processing method, it has the potential to remodel and support new tissue growth. Allograft implants eliminate the need for a second surgery site to obtain the patient's own tissue (autograft) for transplantation to the primary surgery site.

  • Xenograft: A xenograft implant is tissue derived from one species to be implanted in another. Xenograft can be precision-shaped and implanted like an allograft implant. Depending on the type of xenograft, surgical application, and processing method, studies show that it has the potential to remodel into the patient’s body like an allograft implant.

Tissue Sterilization

When possible, RTI has advanced beyond the use of aseptic processing alone, which does not fully address the inactivation of microorganisms inherent to the donor tissue. Sterilization processing adds a measure of safety above screening and testing alone. To achieve sterilization, individual processes should be validated by tissue type. Validation should include tissue penetration, viral inactivation, removal of a wide range of organisms using most difficult case testing and retention of biocompatibility and tissue functionality.

  • Scientifically proven, validated sterilization processes that thoroughly penetrate tissue
  • Able to inactivate pathogens and remove bacteria, viruses, fungi and spores
  • Designed to preserve biomechanical/biochemical integrity and native tissue
  • Validated by individual tissue type based on most difficult case testing using most difficult to kill organisms

*Data on file at RTI Surgical®


The BioCleanse Tissue Sterilization Process is an automated, pharmaceutical-grade process that sterilizes grafts that provide a natural biologic scaffold in orthopedic, spine and sports medicine procedures.

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The Tutoplast Tissue Sterilization Process sterilizes and preserves bone implants, membranes and other soft tissue grafts used in hernia, dental repair and other procedures for implantation.

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The Cancelle SP DBM Sterilization Process preserves protein activity and sterilizes demineralized bone matrix. In their final form, the DBM grafts serve as bone void fillers in a variety of clinical applications, including spine, trauma, joint reconstruction, extremities and dental surgeries.

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