Products & Implants

Products & Implants


nanOss® Bioactive 3D Bone Void Filler

nanOss<sup>®</sup> 3D Advanced Bone Graft Substitute - 1

nanOss Bioactive 3D bone void filler is an advanced bone graft composed of nano-structured HA granules suspended in a porous gelatin-based foam matrix.

Regulatory approvals vary by country. Therefore, we kindly ask you to contact the distributor in your region regarding availability of specific products, implants and / or instrumentation in your region. Please note that this presentation is not valid for Germany. If you seek information on grafts and implants available in Germany, please visit the Germany section on this website.

nanOss<sup>®</sup> 3D Advanced Bone Graft Substitute - 1


  • Large Surface Area

    nanOss Bioactive 3D is composed of nano-structured HA that has a large surface area. The nano-structured HA in these advanced bone graft substitutes has approximately 100X more surface area than competitive synthetic based*products. 2,3 Large surface area allows increased potential for cell attachment.

    Similar to Bone

    Nano-structured HA is similar to bone, which increases its potential to remodel into new bone. Nano-structured HA is a similar size as bone, similar composition as bone and similar shape as bone.

    2Data on file at RTI Surgical, Inc.
    3MacMillan et al. Similar healthy osteoclast and osteoblast activity on nanocrystalline hydroxyapatite and nanoparticles of tri-calcium phosphate compared to natural bone. International Journal of Nanomedicine. Volume 2014:9(1). 5627-5637. The authors would like to thank RTI Surgical for funding the proposed study.
    *A product that is manufactured from synthetic material, but may also include carrier materials derived from non-human materials.

  • nanOss Bioactive 3D is provided sterile by prior exposure to gamma irradiation. It cannot be resterilised by any method.

  • INDlCATlONS:

    nanOss Bioactive 3D is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the spine in conjunction with bone marrow aspirate or bone marrow aspirate and autograft bone. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

    CONTRAINDICATIONS:

    Use of nanOss Bioactive 3D is contraindicated in the presence of one or more of the following clinical situations:

    • metabolic or systemic bone disorders that affect bone or wound healing

    • fractures for which stabilization of the fracture is not possible

    • significant vascular impairment proximal to the graft site

    • infected or contaminated wounds, or fractures for which intraoperative soft tissue coverage is not planned or possible

    • acute and chronic infections in the surgical area (soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis)

    • impaired calcium metabolism

    • treatment with steroids and other drugs affecting calcium metabolism

    • immunosuppressant therapy

    • patients allergic to porcine collagen products

    WARNINGS:

    One of the potential risks identified with any surgical procedure is death. Other potential risks which may require additional surgery, include:

    • inflammation

    • infection

    • neurological injury

    • vascular or visceral injury

    • implant migration

    • non‐union or delayed union

    nanOss Bioactive 3D does not possess sufficient mechanical strength to support the reduction of a fracture site prior to soft and hard tissue in-growth or to support a load. Standard internal fixation techniques such as the use of plates and/or screws must be followed to obtain rigid stabilization. External stabilization alone is not sufficient to achieve the rigidity necessary for bony in-growth of the nanOss Bioactive 3D material. nanOss Bioactive 3D must not be used to gain screw purchase or to stabilize screw placement. Screws used with nanOss Bioactive 3D and fixation devices must attain rigid fixation into the host bone.

    Do not use nanOss Bioactive 3D where complete soft tissue coverage cannot be achieved.

    This system has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for heating or migration in the MR environment.

    PRECAUTIONS:

    • nanOss Bioactive 3D is intended for use only by surgeons familiar with bone grafting and rigid fixation techniques.

    • nanOss Bioactive 3D is radiopaque and the radiopacity may mask underlying pathological conditions.

    • nanOss Bioactive 3D is intended for single use only.

    • Always follow recommended mixing instructions when rehydrating nanOss Bioactive 3D.

    • Do not apply nanOss Bioactive 3D dry to the defect.

    • Do not resterilize nanOss Bioactive 3D.

    • Discard any un-used nanOss Bioactive 3D.

    • Do not expose nanOss Bioactive 3D to temperature extremes such as freezing or excessive heat.

    • nanOss Bioactive 3D has no weight bearing function.

    • The use of non‐steroidal, anti‐inflammatory drugs or other immune modulators should be avoided as they may inhibit bone fusion.

    • For best results, product should fill the defect and contact viable bone as much as possible. Overfilling the defect site should be avoided.

    • Postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting. Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices.