Spinalogic®
CMF Spinalogic® is a portable, battery-powered, micro-controlled, noninvasive bone growth stimulator indicated for skeletally mature patients as an adjunct electromagnetic treatment to:
- Primary lumbar spinal fusion surgery for one or two levels
- Primary anterior cervical discectomy and fusion (ACDF) surgery of 2 motion segments (3 vertebrae) from C4-C7
With just 30 minutes of daily treatment, Spinalogic helps support successful cervical and lumbar fusion outcomes.
One Therapy. Expanded Coverage.
Proven Results.
Now indicated for both lumbar and cervical spine fusion procedures, Spinalogic provides a convenient, noninvasive treatment option that can help improve fusion outcomes while fitting easily into a patient's daily routine. With only 30 minutes of use per day, patients can benefit from a therapy shown to significantly improve fusion success rates in indicated cervical procedures.
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Designed with patient comfort in mind
Lightweight device with custom strap for maximum patient comfort
Can be applied over a brace or clothing
Built in compliance tracking
One button technology for ease of use
Experienced customer service support team available to all patients
Personalized service by highly trained account representatives available to size, fit and train patients.
Scientifically Relevant
- Normal functional activity induces a range of low frequencies from 10 – 150Hz1
- When studied, results proved that lower frequencies, similar to those generated intrinsically by functional activity produce the maximum bone cell response1
- Resorption of bone is lowest and new bone formation is greatest when the power of the induced electrical field is concentrated in the very low frequency range.1
More Advanced Technology*
- 30 minute daily treatment can improve patient compliance29
- 21% increase in primary lumbar fusions over placebo device8
| Company | Technology | PMA Daily Wear Time |
|---|---|---|
| DJO® 1 | Combined Magnetic Field (CMF™) | 30 Minutes |
| Zimmer Biomet™2 | Capacitive Coupling | 24 Hours |
| Orthofix®3 | Pulsed Electromanetic Field | 2-8 Hours |
CMF Spinalogic® bone growth stimulation brief prescribing information
INDICATION: The Spinalogic is a portable, battery powered, micro-controlled, noninvasive bone growth stimulator indicated for skeletally mature patients as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels and adjunct use following primary anterior cervical discectomy and fusion (ACDF) surgery of 2 motion segments (3 vertebrae) from C4 - C7.
CONTRAINDICATIONS: Demand-type pacemaker and implantable cardiovertor defibrillator (ICD) operation may beadversely affected by exposure to combined static and dynamic magnetic fields. Physicians should not prescribe CMF Spinalogic for patients with such devices. The safety and effectiveness of CMF Spinalogic 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 CMF Spinalogic, 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 CMF Spinalogic 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.
Melinda's Story of Recovery with Spinalogic
CMF Signal Science
Using Your Control Unit
Inserting and replacing your batteries
Applying your device lumbar spine
Spinalogic How to Apply - Spanish
How to Use Your CMF Control Unit – Spanish
How to Insert and Replace Batteries on Your CMF Unit – Spanish
- Designed as a lightweight device with a cushioned strap for enhanced patient comfort.
- Can be applied over a cast, brace, or clothing.
- Advanced Combined Magnetic Field (CMF) technology designed to support patient compliance and ease of use.28
- Simple one-button operation.
- Experienced customer support team available to assist patients throughout their treatment journey.
- Personalized support from highly trained account representatives for device sizing, fitting, and patient education.
Ordering Information
| Part Number | Description |
|---|---|
| 01-207-0007 | CMF SpinaLogic |
Accessories
| Part Number | Description |
|---|---|
| 11-1520 | Soft Goods Kit |
| 11-9102 | Extension Belt |
| 25-100-0049 | Batteries |
Patient Application Guide(s):
Instructions for use:
- Based on comparison of FDA approval dates for all electrical stimulators.
- Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, Yuan HA. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999;24(13):1349-1356.
- PMA P850007/S6. February 1990 and Jenis, Louis G., et al. "Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis." Clinical Spine Surgery 13.4 (2000): 290-296.
- Dates represent first FDA approval of technology – technology may have been approved for other products at later dates. ⁵McLeod, K.J., Rubin, C.T., The Effect of Low Frequency Electrical Fields on Osteogenesis. J. Bone Joint Surg., 74A: 920 – 929, 1992.
- 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.
- The only technology approved and with clinical evidence at 30 minutes per day.
- Linovitz R, Pathria M, Bernhardt M, et al. Combined Magnetic Fields Accelerate and Increase Spine Fusion: A Double-Blind, Randomized, Placebo Controlled Study, Spine. 2002 July; 27(13):1383-1388.
- https://www.spine.org/coverage
- Raiszadeh, Ramin, et al. “Effectiveness of combined magnetic field bone growth stimulation on lumbar spinal fusion outcomes: a single center retrospective analysis comparing combined magnetic field to no-stimulation.” International Journal of Research in Orthopaedics 6.3 (2020): 1. A retrospective study that utilized radiographic fusion criteria, included data from 4 surgeons, consisted of a heterogenous patient population and had minimum 6 months follow up.
- McLeod, K.J., Rubin, C.T., The Effect of Low Frequency Electrical Fields on Osteogensis. J. Bone Joint Surg., 74A: 920-929, 1992.
- 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