Demineralized Cortical Bone Powder 125 – 850 μm Quantity
Demineralized Cortical Bone Powder 125 – 850 μm 0.5 cc
Demineralized Cortical Bone Powder 125 – 850 μm 1 cc
Demineralized Cortical Bone Powder 125 – 850 μm 2 cc
Cortical Cancellous Bone Powder 125 – 850 μm Quantity
Cortical Cancellous Bone Powder 125 – 850 μm 0.5 cc
Cortical Cancellous Bone Powder 125 – 850 μm 1 cc
Cortical Cancellous Bone Powder 125 – 850 μm 2 cc
Cancellous Bone Powder 125 – 850 μm Quantity
Cancellous Bone Powder 125 – 850 μm 0.5 cc
Cancellous Bone Powder 125 – 850 μm 1 cc
Cancellous Bone Powder 125 – 850 μm 2 cc

Allograft safety and quality

Advanced tissue processing and quality systems ensure that each and every allograft meets safety and regulatory requirements. These quality standards are written to meet regulations established by the FDA, AATB (American Association of Tissue Banks), Health Canada, and other guidelines as appropriate.

As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted. However, this risk is greatly reduced by using processing treatments shown to be capable of reducing this risk as well as the use of strict donor screening criteria, laboratory testing, aseptic processing and gamma irradiation of the final product.
See Instructions for Use

To order any OSSIX product, call OraPharma at 866-273-7846

INDICATION

OSSIX® GRAFT particulate allograft products consist of cortical bone matrix and may be used in a variety of reconstructive, periodontal, and oral maxillofacial procedures. OSSIX® GRAFT contains Human Cellular and Tissue Based Product (HCT/P).

IMPORTANT SAFETY INFORMATION:

  • OSSIX® GRAFT is contraindicated in:
    • Active or latent infection at the surgical implantation site.
    • Sensitivity or allergies to any of the processing agents listed under the Processing section of the Instructions for Use. Processing agents may include some or all of the following: Bacitracin, Polymyxin B Sulfate, Gentamicin, Allowash, alcohol and/or hydrogen peroxide.
    • Use in immunocompromised patients.
  • As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted.
  • Single patient, single use only. Do not sterilize or re-sterilize.
  • Do not use if the packaging or labeling is damaged or has flaws. Do not use if the expiration date has been exceeded.
  • Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or clinician. Do not use if tissue has not been stored according to the recommended storage instructions.
  • Prior to clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the product.
  • Antibiotic acceptability must be discussed with the patient to discern patient status regarding antibiotic sensitivity.
  • Use standard practices for handling and disposal of human tissue.
  • Inherent uncertainty exists in medical and social histories and lab testing which may not detect known or unknown pathogens. Therefore, the following complications may occur with tissue transplantation:
    • Transmission of diseases of unknown etiology;
    • Bacterial or fungal infection;
    • Immune rejection of implanted HCT/P; or
    • Loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation, and/or disintegration.
  • Maintain documentation about the disposition of each tissue to enable tracking from the donor to the consignee or final disposition. Complete and submit the Allograft Tracing Record (ATR) using preprinted labels included with every graft.
    • Although efforts have been made to ensure the safety of allograft material, current technologies may not preclude the transmission of disease. Adverse outcomes potentially attributable to the tissue or unanticipated or adverse events must be reported immediately to your distributor. USA: 1-800-321-4576.

Click here for Instructions for Use.