INDICATION

OSSIX® Bone is a sterile, biocompatible bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

Important safety Information:

  • OSSIX® Bone must not be used in:
    • Patients with known collagen hypersensitivity.
    • Patients with a sensitivity to porcine-derived materials.
    • Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
    • Patients with acute or chronic infection (osteomyelitis) at the surgical site.
    • Patients with vascular impairment at the implant site.
    • Patients with uncontrolled periodontal disease.
    • Patients that have received or are currently receiving treatment with bisphosphonates.
    • OSSIX® Bone should not be used in the presence of infected wounds at the site of implantation.
  • OSSIX® Bone is intended for a single use only. Do not re-sterilize or reuse.
  • As OSSIX® Bone contains collagen, allergic reactions (e.g. erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Please see accompanying Instructions for Use or Click here for Instructions for Use.

INDICATION

OSSIX Plus® biodegradable collagen membrane is intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

Important safety Information:

  • OSSIX Plus® must not be used in:
    • Patients with known collagen hypersensitivity
    • Patients with a sensitivity to porcine-derived materials
    • Patients suffering from autoimmune disease and connective tissue disease, such as systemic lupus erythematosus, dermatomyositis, etc.
  • OSSIX Plus® is intended for use as a single use device. Do not resterilize.
  • Treatment of high risk patients, such as smokers and patients with uncontrolled diabetes or periodontal disease, may be impaired. Infection control and good oral hygiene should be achieved prior to surgical intervention.
  • Clinical and post marketing experience with OSSIX Plus® reveals an excellent safety profile. Adverse reactions with OSSIX Plus® were not observed. Yet, as the membrane is of a collagen origin, allergic reactions (e.g., erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Please see accompanying Instructions for Use Click here for Instructions for Use.

INDICATION

OSSIX® Volumax biodegradable collagen membrane is intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

IMPORTANT SAFETY INFORMATION:

  • OSSIX® Volumax must not be used in:
    • Patients with known collagen hypersensitivity
    • Patients with a sensitivity to porcine-derived materials
    • Patients suffering from autoimmune disease and connective tissue disease, such as systemic lupus erythematosus, dermatomyositis, etc.
  • OSSIX® Volumax is intended for use as a single use device. Do not resterilize.
  • Treatment of high risk patients, such as smokers and patients with uncontrolled diabetes or periodontal disease, may be impaired. Infection control and good oral hygiene should be achieved prior to surgical intervention.
  • Clinical and post marketing experience with OSSIX Plus®, which is a thinner version of the membrane, reveals an excellent safety profile. Adverse reactions with OSSIX Plus® were not observed. Yet, as the membrane is of a collagen origin, allergic reactions (e.g., erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Please see accompanying Instructions for Use Click here for Instructions for Use.

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.

Please see accompanying Instructions for Use Click here for Instructions for Use.