• nanOss Loaded’s nano-structured hydroxyapatite (HA) have extremely high surface area which provides for more cell attachment sites for osteoclasts and osteoblasts, resulting in potential for improved mineralization, remodeling and bone formation.
• Solid bone formation results from attachment of osteoblasts to the surface of the nano-structured HA and integration of the crystals into newly formed bone.
• nanOss Loaded fully incorporates into the patient’s own newly-formed bone resulting in a fusion mass* – this is the ultimate goal of any bone graft.
• Pre-filled mixing syringe is a closed system for consistency, sterility, compression, and easy delivery of nanOss.
• Adapter allows for quick connection of the bone graft delivery syringe to nanOss Loaded for more precise graft placement in posterolateral fusion procedures.

*C. Lauryssen MD*, S. Robbins MD* & M. Songer MD*. Lumbar Spinal Fusion Results Using nanOss: One Year Follow-Up. 2012 *Served as clinical evaluator/consultant of nanOss in posterolateral spine fusion and compensated for time summarizing patient oucomes, also were shareholders or option holders of Pioneer Surgical stock at the time they authored the study.

nanOss^® Loaded Advanced Bone Graft Substitute is provided sterile by prior exposure to gamma irradiation. nanOss^® Loaded Advanced Bone Graft Substitute cannot be resterilized by any method.

Indications

nanOss Loaded 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 skeletal system (extremities, pelvis) in conjunction with autogenous blood or sterile saline or used in the posterolateral spine in conjunction with 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 with bone during the healing process.

Contraindications

Use of nanOss Loaded 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

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

Complete postoperative wound closure is essential. nanOss Loaded must not be used to repair metaphyseal defects where complete soft tissue coverage cannot be achieved.

• nanOss Loaded must not be used to gain screw purchase or to stabilize screw placement. All screws used in conjunction with this product and fixation devices must attain rigid fixation into the host bone.
• Never introduce nanOss Loaded into closed cavities under pressure, as this may lead to fat embolization or embolization of device into blood stream; and avoid application of nanOss Loaded beyond intended treatment site, as this may damage surrounding tissues. Avoid application of nanOss Loaded beyond intended treatment site as this may damage surrounding tissue.
• Avoid application of nanOss Loaded beyond intended treatment site, as this may damage surrounding tissues.

Precautions

nanOss Loaded is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Standard postoperative practices for the treatment and rehabilitation of extremities that have received open reduction and internal fixation with bone grafting must be strictly followed.

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

nanOss Loaded is intended for single use only.

• do not apply nanOss Loaded dry to the defect.
• do not resterilize nanOss Loaded.
• discard any un-used nanOss Loaded.
• nanOss Loaded has no weight bearing function.

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