OL1000

OL1000 - Family
OL1000 - front
OL1000 - 3/4
OL1000 - 01 - side
OL1000 - front
OL1000 - 01 - Size 1
OL1000 - Size 11 3/4
OL1000 - Size 21 3/4
OL1000 - Size 2 - Front
OL1000 - Family
OL1000 - front
OL1000 - 3/4
OL1000 - 01 - side
OL1000 - front
OL1000 - 01 - Size 1
OL1000 - Size 11 3/4
OL1000 - Size 21 3/4
OL1000 - Size 2 - Front
Regeneration

OL1000™

PFATS

CMF OL1000 Bone Growth Stimulators are portable, battery-powered medical devices indicated for use in the noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bones. The device was designed with following features:

  • Lightweight and comfortable
  • Easy-to-use & Noninvasive
  • Requires simple, one-button operation
  • Device is worn for 30 minutes per day
  • Can be used with internal or external fixation or over a cast

This treatment has been shown in pre-clinical studies to help the body’s own healing process begin working. Clinical studies reported success rates as high as 89%.3

Contact a Sales Representative for more information.

 

Published April 2021: New study observed significant cost savings with use of OL1000 vs. surgical intervention. View Study Results.

  • Overview
  • Videos
  • Part Numbers
  • Documents
  • References

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.

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Using Your Control Unit

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Inserting and replacing your batteries

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Fracture Dual Coil

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Fracture Size One

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Fracture sizes 2, 3, and 4

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CMF OL1000 Fracture Size One - How to Apply

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CMF OL1000 Size 1 How to Apply Video - Spanish

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CMF OL1000 Size 2, 3, 4 How to Apply – Spanish

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CMF OL1000 Dual Coil How to Apply – Spanish

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How to Use Your CMF Control Unit – Spanish

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How to Insert and Replace Batteries on Your CMF Unit – Spanish

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Bone Growth Stimulation – How to apply your OL1000 Size 1

Ordering Information

Part Number Description Size
01-203-0001 CMF OL1000 Dual Coil n/a
01-211-0001 CMF OL1000 Single Coil 1
01-211-0002 CMF OL1000 Single Coil 2
01-211-0003 CMF OL1000 Single Coil 3
01-211-0004 CMF OL1000 Single Coil 4

Accessories

Part Number Description
11-0214 Holster Clip
25-100-0049 Batteries
13-2104 Patient Manual
25-111-0001 Small Strap (Single Coil use only)
25-111-0002 Large Strap (Single Coil use only)
25-111-0003 Shoulder Strap (Single Coil use only)

 

  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).
  4. Enovis™ 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