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Bonestims

Leg & Ankle Bone Stimulator

Leg & Ankle Bone Stimulator

$4,995.00 USD
$4,995.00 USD
Sale Sold out

A fracture in Humerus, Femur, Tibia/Fibula & Ankle area can result from significant force, leading to severe pain and functional impairment. After a fracture, issues such as reduced mobility, pain, and more, impacting overall movement. The REGENERATION OL1000™ is designed for the thigh, allowing placement over clothing, braces, or casts. Direct body contact isn't necessary for treatment, but proper coil positioning around the fracture site is crucial for effectiveness. Users can easily shape the coils for a more comfortable fit.

This Bone Growth Stimulators are portable, battery-powered medical devices intended for the noninvasive treatment of established nonunion fractures caused by trauma, excluding vertebrae and flat bones. The device was crafted with the following characteristics:

  • Lightweight and cozy
  • Simple to operate and noninvasive
  • Operates with just one button
  • Worn for 30 minutes daily
  • Compatible with internal or external fixation or worn over a cast

Preclinical research demonstrates that this therapy initiates the body's natural healing mechanisms. Clinical trials have documented success rates reaching up to 89%.

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BRIEF PRESCRIBING INFORMATION

INDICATIONS: 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: Use of this device is contraindicated in individuals having a synovial pseudarthrosis. Demand-type pacemaker or implantable cardioverter defibrillator (ICD) operation may be adversely affected by exposure to magnetic fields. Physicians should not prescribe CMF 0L1000 for applications that may place the treatment transducers in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram). CMF 0L1000 should not be used in the presence of external or internal fixation devices that are constructed from magnetic materials.

(NOTE: Almost all fracture fixation devices implanted today are made from nonmagnetic materials.)

WARNINGS: The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established. Animal studies conducted to date do not suggest any long-term significant adverse effects from use of this device. However, long-term effects in humans are unknown. Teratological studies have not been performed with this device. The safety of use of this device during pregnancy or nursing in humans has not been established.

PRECAUTIONS: Weight bearing is not advised in the presence of extreme motion at the nonunion site. In the presence of a malaligned nonunion, careful consideration of the use of this device must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment. The safety and effectiveness of the use of this device on individuals with nonunion secondary to, or in conjunction with, a pathological condition have not been established. This device should not be used if there are mental or physical conditions that preclude patient compliance with the physician and device instructions. When conditions of atrophy are present or when fractures have remained unhealed for long periods of time, there may be less successful results.

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 the OL1000, which has the same treatment signal as the OL1000 SC1, have not indicated any evidence of significant adverse effects.

CAUTION: Federal law (U.S.A. and Canada) restricts this device to sale, distribution or use by or on the order of a physician.

  1. Mcleod, Kenneth J., and C. T. Rubin. "The effect of low-frequency electrical fields on osteogenesis." J Bone Joint Surg Am 74.6 (1992): 920-9.
  2. [PMA 910066] Phillips, Mark, et al. "The Use of Combined Magnetic Field Treatment for Fracture Nonunion: A Prospective Observational Study." Journal of Long-Term Effects of Medical Implants 26.3 (2016).
  3. [P910066 / S005] Phillips, Mark, et al. "Use of Combined Magnetic Field Treatment for Fracture Nonunion." Journal of Long-Term Effects of Medical Implants 26.3 (2016).