Indications
nanOss 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 (i.e., extremities, posterolateral spine, and pelvis). nanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. nanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. 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 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 does not possess sufficient mechanical strength to support the reduction of a fracture site prior to soft and hard tissue ingrowth 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 ingrowth of the nanOss.
- nanOss must not be used to gain screw purchase or to stabilize screw placement. Screws used in conjunction with this product and fixation devices must attain rigid fixation into the host bone.
- Complete postoperative wound closure is essential. nanOss must not be used to repair metaphyseal defects where complete soft tissue coverage cannot be achieved.
- Avoid application of nanOss beyond intended treatment site, as this may damage surrounding tissues.
- The following additional warnings apply when using nanOss Loaded provided in a mixing chamber: — Never introduce nanOss into closed cavities under pressure, as this may lead to fat embolization or embolization of device into blood stream. — Avoid over-pressurizing the device because this may lead to extrusion of the device beyond the site of its intended application and damage to the surrounding tissues. — When mixing nanOss with autograft for use in posterolateral spine and using the graft applicator, morselize autograft particles to smaller than 2mm to prevent risk of clogging. Use of a bone mill to morselize autograft prior to addition to nanOss is recommended for best results.
- 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 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.
- Placement of nanOss will be determined by the site, size and configuration of the defect. nanOss does not possess sufficient mechanical strength to support the reduction of a fracture site prior to tissue in-growth or to support a load. Anatomical reduction and rigid internal fixation must be obtained independently of nanOss. Accepted internal fixation techniques must be used until ingrowth has occurred and the site is healed.
- Fixation must be appropriate to reduce loading of the nanOss site in order to prevent collapse or deformity. Plates and/or screws are preferred for primary fixation.
- nanOss granules are radiopaque and the radiopacity may mask underlying pathological conditions.
- nanOss is intended for single use only.
- Do not resterilize nanOss.
- Discard any un-used nanOss.
- Do not expose to temperature extremes such as freezing or excessive heat.
- Do not apply nanOss dry to the defect.
- nanOss has no weight bearing function.
- Postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting. Hardware should not be removed until complete healing has taken place. The length of time required for a reduced state of loading will be determined by the complexity of the defect and the patient’s physical condition. The patient should be cautioned against premature ambulation and early weight bearing.
- For best results, nanOss should fill the defect and contact viable bone as much as possible. Over-filling the defect site should be avoided
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.
