The bioactive response of Cortoss has not been assessed in any clinical investigation and the results from laboratory or animal testing may not be predictive of human clinical experience
U.S. Food and Drug Administration, Center for Devices and Radiological Health. SpineJack Expansion Kit 510(k) Summary (K181262). Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181262
Tzermiadianos M et al. Altered disc pressure profile after an osteoporotic vertebral fracture is a risk factor for adjacent vertebral body fracture. European Spine Journal. 2008; 17:1522-1530
Hulme P et al. Vertebroplasty and kyphoplasty: A systematic review of 69 clinical studies. Spine. 2006; 31(17):1983-2001.
iVAS Elite Inflatable Vertebral Augmentation System Instructions for Use: 0808-000-700 Rev-AA
As compared to larger gauge sizes
As of July 2019
Based on fill volume
As of July 2019
An Evaluation of the Safety and Efficacy of an Alternative Material to Polymethylmethacrylate Bone Cement for Vertebral Augmentation. 5702-0004, Rev. 00
Bae, H., et al, A Prospective Randomized FDA-IDE Trial Comparing Cortoss to PMMA for Vertebroplasty: A Comparative Effectiveness Research Study with 24-Months Follow-Up. Spine, first published on July 5, 2011 as doi: 10.1097/ BRS.0b013e31822ba50b
Deramond H, Wright NT, Belko? SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone, 1999. Vol 25 (2) 17S-21S
Pomrink, et al., Evaluation of the reaction kinetics of Cortoss, a thermoset cortical bone void ller. Biomaterials, 2003, Vol. 24 (6) 1023-1031
Cortoss Bone Augmentation Material: Instructions for Use (IFU)
Palussière, Jean et al. "Clinical Results Of An Open Prospective Study Of A Bis-GMA Composite In Percutaneous Vertebral Augmentation". European Spine Journal 14.10 (2005): 982-991. Web. 18 Aug. 2016
Bae, Hyun et al. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web
Independent lab results from Fluid Dynamics Inc. commissioned by Stryker July 2009. Testing conducted at 20-21° C (68-70° F)
The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 11
Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 22
Based on 18g Venom Cannula and Electrode System
Stryker Corporation. (2013). Effect of the Stryker Venom Cannula and Venom Electrode Combination on Lesion Size and Anesthesia Delivery During Radiofrequency Ablation[Clinical white paper, 1000-025-195 Rev None]. Kalamazoo, MI.
Amoretti N, David P, Grimaud A, Flory P, Hovorka I, Roux C, Chevallier P, Bruneton JN. Clinical follow-up of 50 patients treated by percutaneous lumbar discectomy. Clinical Imaging. 2006; 30(4):242-4
Alò K, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: clinical response in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Practice 2004; 4:19-29
Alò KM, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: one-year follow-up in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Pract. 2005; 5(2):116-23
Alò K, Wright RE, Fu ZJ. Open human torso laboratory dissection with annular and nuclear lumbar disc analysis pre and post Dekompressor®. Denver, CO: University of Colorado Health Sciences Center College of Medicine, Department of Anatomy; January 19/20, 2003
Wright R. Preclinical laboratory analysis of Dekompressor® percutaneous decompression in sheep and human cadaver discs: Internal Data. Fort Collins, CO: Colorado State University; May 2000
