References
1. Grafton DBM has been FDA (510k) cleared as a bone graft substitute, bone graft extender, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure.
2. Data on File. 04-007A Summary Report Osteoinduction of Competitor Materials in the Athymic Rat. Grafton DBM as compared to the osteoinductivity of Osteofil, Dynagraft II, Allomatrix, DBX, Accell DBM 100, Intergro DBM, and Orthoblast II, when measured in the athymic rat.
3. Martin, G.J., Boden, S.D., Titus, L., and Scarborough, N.L.: New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthodesis. Spine 24 (7):637. 1999.
4. Khan, Safdar N. et al. "Use of Osteopromotive Growth Factors, Demineralized Bone Matrix, and Ceramics to Enhance Spiral Fusion. J Am Acad Orthop Surg 2005; 13:12-137
5. B Peterson, MD, et al. "Osteoinductivity of Commercially Available Demineralized Bone Matrix: Preparations in a Spine Fusion Model. Journal of Bone & Joint Surgery, October 2004, 86-A No. 10.
6. Performance in this model is not a predictor of clinical performance.
7. W Sassard, et al. "Augmenting Local Bone with Grafton® Demineralized Bone Matrix for Posterolateral Lumbar Spine Fusion: Avoiding Second Site Autologous Bone Harvest"
Orthopedics 2000, Vol. 23, No.10.
8. J Louis-Ugbo, SD Boden, et al. "Evidence of Osteoinduction by Grafton® Demineralized Bone Matrix in Nonhuman Primate Spinal Fusion" SPINE Volume 29, No 4. February, 2004.
9. FP Cammisa, et al "Two-Year Fusion Rate Equivalency Between Grafton® DBM Gel and Autograft in Posterolateral Spine Fusion". SPINE Volume 29, No 6. March 2004.
10. J Kang, et al. "Grafton® & Local Bone Has Comparable Outcomes to Iliac Crest Bone in Single Level Lumbar Fusions" (WP122)