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Frequently Asked Questions
Below, questions we have received over the years have been archived for your convenience. If your question is not answered below, please contact us today.
1. Is TruFUSE® FDA approved?
2. Why would I use an allograft product to fuse the facets?
3. What does the biomechanical data yield about the strength of TruFUSE®?
4. How is fusion assessed?
1. Is TruFUSE® FDA approved?
Yes. Donated human tissue production and processing is regulated by the FDA under 21 CFR Part 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS. TruFUSE® Allograft is processed by licensed tissue banks which are fully compliant with all FDA requirements for tissue processing in the United States.
2. Why would I use an allograft product to fuse the facets?
Bone dowels are a new product made of allograft. The Morse taper design could provide a more stable method of fusion versus older methods of fusing the facet joint. The premise of TruFUSE is to provide stability for primary and secondary bone healing and fusion.
3. What does the biomechanical data yield about the strength of TruFUSE®?
As the following graphs show, TruFUSE compares very favorably to the published biomechanical data of other devices. TruFUSE could provide comparable stability of the spine without the risk of catastrophic failure or permanent compromise of the facet joint. TruFUSE fixation allows micro motion while still firmly limiting range of motion, which theoretically stimulates the body’s natural healing response.
Comparative stiffness testing of intact spine segment and segment implanted with TruFUSE allograft dowels vs. published data.
4. How is fusion assessed?
Fusion can be assessed on radiographic grounds. Radiographically, flexion and extension x-rays help document motion. Fine cut CT scans or bone scans can also be used.
Below, questions we have received over the years have been archived for your convenience. If your question is not answered below, please contact us today.
1. Is TruFUSE® FDA approved?
2. Why would I use an allograft product to fuse the facets?
3. What does the biomechanical data yield about the strength of TruFUSE®?
4. How is fusion assessed?
1. Is TruFUSE® FDA approved?
Yes. Donated human tissue production and processing is regulated by the FDA under 21 CFR Part 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS. TruFUSE® Allograft is processed by licensed tissue banks which are fully compliant with all FDA requirements for tissue processing in the United States.
2. Why would I use an allograft product to fuse the facets?
Bone dowels are a new product made of allograft. The Morse taper design could provide a more stable method of fusion versus older methods of fusing the facet joint. The premise of TruFUSE is to provide stability for primary and secondary bone healing and fusion.
3. What does the biomechanical data yield about the strength of TruFUSE®?
As the following graphs show, TruFUSE compares very favorably to the published biomechanical data of other devices. TruFUSE could provide comparable stability of the spine without the risk of catastrophic failure or permanent compromise of the facet joint. TruFUSE fixation allows micro motion while still firmly limiting range of motion, which theoretically stimulates the body’s natural healing response.
Comparative stiffness testing of intact spine segment and segment implanted with TruFUSE allograft dowels vs. published data.
4. How is fusion assessed?
Fusion can be assessed on radiographic grounds. Radiographically, flexion and extension x-rays help document motion. Fine cut CT scans or bone scans can also be used.