i-FACTOR Peptide Enhanced Bone Graft Technology Platform

i-FACTOR Bone Graft is an advanced biologic that is supported with level I evidence, satisfies the highest regulatory imperatives, and provides a better cost/benefit ratio than engineered growth factors and cellular allografts.

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Mechanism of Action

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i-FACTOR Bone Graft is the only biologic bone graft made of a synthetic small peptide (P-15) bound to an anorganic bone mineral (ABM). This unique combination creates a surface-bound “Attract, Attach, Activate” mechanism of action that enhances the body’s natural bone healing process. Being surface-bound, all cellular activity resulting from P-15 attachment is restricted to the implant surface so bone cannot grow where it doesn’t belong (ectopic bone growth).

i-FACTOR Bone Graft is not a morphogen so, unlike engineered growth factors, the signals sent following P-15 attachment in a bony site only activate cells that are pre-programmed to become osteoblasts.

i-FACTOR Bone Graft Putty

Product Information

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i-FACTOR Bone Graft products are intended to replace or augment the use of autologous bone commonly utilized in spine, trauma, and orthopedic procedures such as:

*Spinal fusion incorporating interbody fusion devices
*Treatment of non-union or traumatic fresh fractures
*Joint reconstruction requiring a bone void filler

i-FACTOR Bone Graft products are sterilized after packaging (terminally sterilized), can be stored at room temperature and have a three-year shelf life. i-FACTOR Bone Graft is ready to use and thus requires no mixing or other preparation prior to use.

 

 

Handling Instructions

  • When mixing Putty with autograft, ensure a thorough mix resulting in an even spread of granules throughout the structure of the graft material. We recommend a mix ratio of 30% Putty with 70% autograft (the maximum ratio is 50:50). The suggested ratio ensures that a physiologic quantity of natural growth factors is present for fast, safe, and effective fusion.
  • Mix Putty until no obvious clumping of the bone graft can be seen.
  • When used in conjunction with blood or bone marrow aspirate, leave the mixture to stand for 10 to 15 minutes to allow coagulation to occur.
  • Once in position, any loose surface granules should be removed by swabbing and suction prior to wound closure.

IMPORTANT: Do not irrigate once implanted.

Size and Ordering Information

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i-FACTOR Bone Graft Flex FR

Product Information

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i-FACTOR Flex FR, with purified silk, retains the safety and biocompatibility of P-15 technology while providing superior out of packaging handling and in-vivo cohesive properties. Purified silk fibers, an inert carrier, provide enhanced:

-Cohesion
-Mechanical Properties
-Handling Characteristics

This enables i-FACTOR Flex FR to provide significant new application options while retaining the safety and efficacy of P-15 technology.

Handling Instructions

  • Flex FR can be applied directly to the surgical site without the need to soak it with blood. However, adding some blood or BMA improves flexibility and the ability to mold the strip.
  • We recommend placing Flex FR into the surgical site once all hardware has been secured in position and immediately prior to closure.
  • Flex FR can be cut to fit into a cage.
  • When applied directly into a surgical site, we recommend that a layer of autograft be placed on top of the Flex FR.
  • Once in position, any loose surface granules should be removed by swabbing and suction prior to wound closure.

IMPORTANT: Do not irrigate once implanted.

Size and Ordering Information

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