At Pinnacle, safety and quality are our priority. We maintain the highest quality standards from recovery through processing to ensure safety for our employees and patients. Pinnacle is registered with the Food and Drug Administration (FDA), accredited by the American Association of Tissue Banks (AATB) and maintains all applicable state licenses.
At Pinnacle, safety and quality are our priority. We maintain the highest quality standards from recovery through processing to ensure safety for our employees and patients. Pinnacle is registered with the Food and Drug Administration (FDA), accredited by the American Association of Tissue Banks (AATB) and maintains all applicable state licenses.
Recovery or collection of all donated tissues is performed by our recovery partners across the United States using surgical procedures to minimize contamination and bioburden.
Each donor is subjected to a thorough eligibility evaluation (i.e. a donor risk assessment interview with the family, medical records review, infectious disease screening, autopsy report if performed and physical assessment)
As part of the donor screening process, each donor undergoes an extensive panel of serological and microbiological tests. Laboratory testing is performed in a CLIA certified laboratory and includes, but is not limited to, the following:
Based on all screening and testing results, donor tissue is determined to be suitable for transplant by our Medical Director and Quality Assurance Team.
Tissue is subjected to a proprietary series of disinfection soaks and mechanical agitation to decontaminate the tissue, remove blood and lipids, and reduce bioburden. Tissue is cleansed again using a sterile rinse to remove any residual processing reagents, bloods or lipids.
Pinnacle's tissue sterilization process allows bone & soft tissue to maintain biomechanical integrity while achieving a sterility assurance level (SAL) of 10-6.
Recovery or collection of all donated tissues is performed by our recovery partners across the United States using surgical procedures to minimize contamination and bioburden.
Based on all screening and testing results, donor tissue is determined to be suitable for transplant by our Medical Director and Quality Assurance Team.
Each donor is subjected to a thorough eligibility evaluation (i.e. a donor risk assessment interview with the family, medical records review, infectious disease screening, autopsy report if performed and physical assessment)
Tissue is subjected to a proprietary series of disinfection soaks and mechanical agitation to decontaminate the tissue, remove blood and lipids, and reduce bioburden. Tissue is cleansed again using a sterile rinse to remove any residual processing reagents, bloods or lipids.
As part of the donor screening process, each donor undergoes an extensive panel of serological and microbiological tests. Laboratory testing is performed in a CLIA certified laboratory and includes, but is not limited to, the following:
Pinnacle's tissue sterilization process allows bone & soft tissue to maintain biomechanical integrity while achieving a sterility assurance level (SAL) of 10-6.
Precision-machined grafts, demineralized bone matrix/fibers (DBM/DBF) and allograft chips
Soft tissue allografts, with and without bone
Biological overlay for wound healing
Versatile solutions for a wide array of orthopedic applications
Pinnacle is committed to honoring the gift of donation and improving patient’s quality of life through the processing and distribution of high-quality allograft implants.
1125 W. Pinnacle Peak Road, Building #2
Phoenix, AZ 85027
Phone: 623-277-5400
Fax: 623-277-5401
info@pinnacletransplant.com
To request more information or contact a representative from Pinnacle’s Team, please complete the form below