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Allograft Bone & Soft Tissue

Comprehensive Safety & Quality Assurance Program

Donor tissue is obtained through a next-of-kin first person consent program with FDA registered recovery agencies contracted with our production partner. These cadaveric donors undergo a series of pre-production serological and microbiological testing, coupled with an extensive eligibility and suitability determination by a medical director prior to release for implant. In addition, the production partner conducts many in-process tests that are congruent with FDA Regulations 21 CFR 1270 and 1271. Every donor is screened for potential communicable diseases. These tests include, but are not always limited to the following serological tests:

  • Hepatitis B core antigen (HBcAg)
  • Hepatitis C antibodies (HCVAb)
  • Human Immunodeficiency Virus 1/O/2 antibodies (HIV-1/O/2 Ab)
  • Human T-lymphotrophic virus I/II (HTLVI/II)
  • Anti-Hepatitis B core total antibodies (HBcTotal)
  • RPR - Syphilis Testing

Additional Regulatory Classifications

  • All Forma allograft products are processed in ISO Certified Class 5, manufacturing enviroments.
  • All products are tracked in a validated GxP compliant tracking software using serialized inventory controls throughout the entire production through to release for implantation.
  • Forma Allograft is processed by a partner company registered with the United States Food and Drug Administration as a HCT/P establishment.
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Demineralized Crushed Cancellous

  • 1-4mm and 4-10mm sizes in 5, 10, and 30cc volumes
  • Sterilized to a 106 Sterility Assurance Level using a validated sterilization process to preserve native proteins inherent to trabecular tissue
  • Can be used alone or in combination with autograft or Bone Marrow Aspirate for filling boney defects, spinal fusion, or dental applications
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Demineralized Cube

  • 10x10x10mm, 12x12x12mm, 14x14x14mm sizes
  • Sterilized to a 106 Sterility Assurance Level using a validated sterilization process
  • Utilization for spinal surgery and dental mandibular canal applications
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Demineralized Strip

  • Multiple Sizes for use in spinal and dental applications
  • Sterilized to a 106 Sterility Assurance Level using a validated sterilization process
  • Flexible. Can be placed in the lateral gutters in posterolateral spinal fusion or used in cranio-maxillofacial applications
  • Can be used in conjunction with BMA to make graft osteogenic
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DBM Paste

  • 1cc, 2.5cc, 5cc and 10cc Syringe
  • Sterilized to a 106 Sterility Assurance Level using a validated sterilization process
  • Human DBM - No added excipients that can get in the way of bone formation
  • Easy evacuation and retains a hydrophobic quality during irrigation
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DBM Putty

  • 1cc, 2.5cc, 5cc and 10cc Jar
  • Sterilized to a 106 Sterility Assurance Level using a validated sterilization process
  • Human DBM  with Cortical Cancellous Chips
  • Handling – easy shaped into whatever defect or surgical site repair needed.
  • Hydrophobic qualities during irrigation
  • Can be mixed with BMA, PRP