OL1000 ™ BONE GROWTH STIMULATION BRIEF PRESCRIBING INFORMATION
INDICATION: Noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. CONTRAINDICATIONS: Demand-type pacemaker and implantable cardiovertor defibrillator (ICD) operation may be adversely affected by exposure to combined static and dynamic magnetic fields. Physicians should not prescribe OL1000 for patients with such devices. The safety and effectiveness of OL1000 in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown. Thus, this device should not be used in pregnant women. If a woman becomes pregnant during treatment with OL1000, treatment should be discontinued immediately. PRECAUTIONS: The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established. The safety and effectiveness of this device in treating patients with the following conditions have not been established and therefore the safety and effectiveness of the device in these individuals are unknown: osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, severe osteoporosis, metastatic cancer, renal disease, and uncontrolled diabetes mellitus. Animal studies conducted to date do not suggest any long term adverse effects from use of this device. However, long term effects in humans are unknown. Compliance with the treatment schedule, timely battery change and proper care of the device are essential. The device will not perform properly and treatment may be unnecessarily prolonged if the patient fails to adhere to the care routine. This device should not be used if there are mental or physical conditions which preclude patient compliance with the physician and device instructions. ADVERSE EFFECTS: No known significant adverse effects have resulted from the use of this device. Clinical studies, animal studies, and tissue culture experiments conducted with OL1000 Bone Growth Stimulator magnetic fields have not indicated any evidence of significant adverse effects. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For full prescribing information, contact DJO, LLC. 1 DJO CMF PMA: P910066/S005, May 1997 “Tough/Difficult fracture” defined per the following: Success rates obtained on fractures greater than 9 months post injury; Mean time since initial injury = 29.3 months; Mean number of prior surgeries = 2.5 2 Baumhauer Phillips M, Baumhauer J, Sprague S, Zoltan J. Use of Combined Magnetic Field Treatment for Fracture Nonunion. J Long Term Eff Med Implants. 2016;26(3):277-284. doi: 10.1615/JLongTermEffMedImplants.2016016818. PMID: 28134611. 3 Stewart SK. Fracture Non-Union: A Review of Clinical Challenges and Future Research Needs. Malays Orthop J. 2019;13(2):1-10. doi:10.5704/ MOJ.1907.001 4 https://orthoinfo.aaos.org/en/diseases--conditions/nonunions 5 Thomas JD, Kehoe JL. Bone Nonunion. [Updated 2020 May 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554385/ 6 McLeod, K.J., Rubin, C.T., The Effect of Low Frequency Electrical Fields on Osteogensis. J. Bone Joint Surg., 74A: 920-929, 1992. 7 Signal shown in red represents 76.6Hz frequency emitted by CMF Technology 8 Ryaby, J.T., et al., The Role of Insulin-like Growth Factor in Magnetic Field Regulation of Bone Formation, Bioelectrochemistry and Bioenergetics, 35: 87-91, 1994. 9 Fitzsimmons, R.J., Ryaby, J.T., Magee, F.P. and Baylink, D.J. (1995), IGF‐II receptor number is increased in TE‐85 osteosarcoma cells by combined magnetic fields. J Bone Miner Res, 10: 812-819. 10 Based on actual frequencies of other technologies (1-50,000HZ, 60,000Hz)
(800) 336-6569 phone (800) 936-6569 fax 2900 Lake Vista Drive Lewisville, TX 95067 U.S.A. djoglobal.com/Regeneration
COPYRIGHT © 2021 DJO, LLC • MKT00-10872 Rev A Individual results may vary. This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call DJO® at 800-336-6569. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.
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