Products & Implants

Products & Implants


nanOss® Bioactive Bone Void Filler

nanOss<sup>®</sup> Bioactive Bone Void Filler

nanOss ® Bioactive is a bone void filler that combines osteoconductive nano-structured hydroxyapatite (HA) and an engineered extracellular matrix bioscaffold (carrier) to provide a natural bone growth solution.1

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.

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> Bioactive Bone Void Filler


  • Large Surface Area

    nanOss Bioactive 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.

    Supports Bone Repair

    The engineered extracellular matrix bioscaffold (carrier) in nanOss Bioactive supports bone repair. 4 Thus, the entire product is helping to remodel bone.

    Peer Reviewed Evidence

    nanOss Bioactive is among the few synthetic based bone grafts with peer-reviewed evidence of posterolateral fusion. 93% of the total individual sites treated exhibited posterolateral bridging bone in a retrospective, multi-center study of 46 patients at approximately 12 months postoperatively. CT scans were analyzed by an independent radiologist for the presence of bridging bone. The study included a small cohort of smokers. 5

    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.
    4Data on file at RTI Surgical, Inc.
    5Robbins, S et al. J Spinal Disord Tech. Use of Nanocrystalline Hydroxyapatite With Autologous BMA and Local Bone in the Lumbar Spine A Retrospective CT Analysis of Posterolateral Fusion Results.

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

  • INDlCATlONS:

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

    • 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:

    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 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 material. nanOss Bioactive must not be used to gain screw purchase or to stabilize screw placement. Screws used with nanOss Bioactive and fixation devices must attain rigid fixation into the host bone.

    Complete postoperative wound closure is essential. nanOss Bioactive must not be used to repair metaphyseal defects where complete soft tissue coverage cannot be achieved. Avoid application of nanOss Bioactive beyond intended treatment site; this may result in product migration and/or damage surrounding tissues.

    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:

    • This product is intended for use only by surgeons familiar with bone grafting and rigid fixation techniques. 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.

    • nanOss Bioactive granules are radiopaque and the radiopacity may mask underlying pathological conditions.

    • nanOss Bioactive is intended for single use only.

    • Do not resterilize nanOss Bioactive.

    • Discard any un-used nanOss Bioactive.

    • Do not expose to temperature extremes such as freezing or excessive heat.

    • Do not apply nanOss Bioactive dry to the defect.

    • nanOss Bioactive has no weight bearing function.

    • Always follow recommended mixing instructions when rehydrating nanOss Bioactive.

    • 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.