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i-FACTOR™ Biologic Bone Graft Product FAQs

How should i-FACTOR Putty and i-FACTOR Flex be used (surgical technique)?

i-FACTOR Putty can be delivered directly to the surgical site or into an implant device (i.e. spinal interbody cage) via the syringe. i-FACTOR bone graft products do not require any pre-mixing with blood or bone marrow but should be placed in a “bleeding bone” environment, such as a fusion bed or fracture site.

i-FACTOR Flex handling characteristics allow it to be used not only in implant devices but also tissue contained areas. i-FACTOR Flex can be cut to fit the particular dimensions of an osseous defect, bony void or containment device. Furthermore, the lyophilization (freeze-drying) process allows i-FACTOR Flex to soak up bone marrow from surrounding host bone after placement.

Does i-FACTOR bone graft need to be mixed with autograft bone, bone marrow aspirate or blood?

No. i-FACTOR provides the appropriate biomimetic structure for osteogenic cell adhesion, proliferation and differentiation, resulting in bone formation. Mixing i-FACTOR bone graft with autograft bone is not necessary as long as i-FACTOR is placed in a bleeding bone environment. Many bone graft substitutes rely on bone marrow aspirate for osteoinductive properties, whereas the synthetic small peptide (P-15™) in i-FACTOR stimulates the bone formation process through natural cell adhesion.

Can i-FACTOR bone graft be mixed with local autograft?

Yes. Often local autograft bone cannot be harvested in enough quantity to facilitate fusion. i-FACTOR bone graft thrives in environments rich with osteogenic precursor cells while extending the overall volume of grafting material. i-Factor Putty can be mixed with autograft, whereas some surgeons will layer autograft with i-FACTOR Flex.

Is i-FACTOR approved for sale in the USA?

No. A clinical trial is currently underway for FDA approval. However, the FDA approved P-15 and anorganic bone mineral (ABM) for dental applications in October 1999. To date, it is the only USA PMA-approved bone graft shown to be clinically superior to both alloplasts and allografts (DBM). In the last 10+ years, it is estimated that there have been over 500,000 implants of ABM/P-15.

Does i-FACTOR bone graft increase in size/volume when placed in situ?

No. i-FACTOR bone graft products will soak up surrounding osteogenic precursor cells from decorticated bone and bony voids but will not expand in size.

Is i-FACTOR bone graft a load-bearing product?

No. i-FACTOR bone graft is not intended to provide load-bearing structural support during the healing process. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes. 

Can i-FACTOR Putty or Flex be re-sterilized or re-used?

No. i-FACTOR Putty and Flex are designed for single patient use only. Do not attempt to re-sterilize or re-use. Discard unused contents according to approved medical waste disposal guidelines.

Is the foil pouch that is part of i-FACTOR Flex packaging a sterile barrier?

No. It is a vapor barrier only that ensures i-FACTOR Flex does not take on moisture and can maintain its handling characteristics.

Can a partially opened i-FACTOR package be placed back on the shelf in materials management?

If the outer foil pouch of either Putty or Flex has been compromised, it should not be placed back into materials management.

How should i-FACTOR bone graft be stored?

i-FACTOR bone graft, in its original packaging, can be stored at ambient room temperature (15°C/59°F to 32°C/90°F). i-FACTOR has a two-year shelf life. Do not use product outside of its expiration date. 

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