Products & Implants

Products & Implants


nanOss® 3D Advanced Bone Graft Substitute

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

nanOss® 3D Advanced Bone Graft Substitute is composed of nano-structured hydroxyapatite 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.

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


    • nanOss 3D is an advanced bone graft that combines an engineered extracellular matrix bioscaffold which is developed as an ideal pathway for cell infiltration and osteoconductive nano-structured hydroxyapatite (HA) that mimic the composition, structure and size of bone,1 providing a natural bone growth solution.
    • nanOss 3D is synthetic human bone.
    • nanOss 3D's nano-structured HA have extremely high surface area for cell attachment. 

    1Ahn, E. & Webster, T. Enhanced Osteoblast & Osteoclast Function on nanOss a Calcium Phosphate Nanotechnology. 2009. *Research and Development, Pioneer Surgical Technology, Greenville, NC & Woburn, MA. Study sponsored by Pioneer Surgical.

    • nanOss 3D is provided sterile by prior exposure to gamma irradiation and intended for single use only.
  • Indications

    nanOss 3D is indicated for bony voids or gaps that are not intrinsic to the stability of bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. nanOss 3D is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis) un-hydrated or in conjunction with bone marrow aspirate or autogenous blood, or in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone as a bone graft extender. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. 

    Contraindications

    Use of nanOss 3D is contraindicated in the presence of one or more of the following conditions:

    • Fractures of the epiphyseal plate.
    • 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.
    • Use in the area of the open epiphyseal growth plate.
    • Patients allergic to porcine collagen products.

    Warnings

    Standard internal fixation techniques such as the use of plates and/or screws must be followed to obtain rigid stabilization. nanOss 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.

    External stabilization alone is not sufficient to achieve the rigidity necessary for bony in-growth of the nanOss 3D material.

    Do not use nanOss 3D to gain screw purchase or to stabilize screw placement. Screws used with nanOss 3D and fixation devices must attain rigid fixation into the host bone.

    Do not use nanOss 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 3D is intended for use only by surgeons familiar with bone grafting and rigid fixation techniques.

    nanOss 3D is radiopaque, so the radiopacity may mask underlying pathological conditions.

    nanOss 3D is intended for single use only.

    Always follow recommended hydration instructions when rehydrating nanOss 3D.

    Do not apply nanOss 3D dry to the posterolateral spine.

    Do not resterilize nanOss 3D.

    Discard any un-used nanOss 3D.

    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.

    See product specific surgical technique manual and package insert for complete instructions and labeling limitations.