OL1000 & Manafuse Bone Growth Stimulators FAQs

Patient FAQs

We are committed to helping patients heal faster, recover confidently, and get back to the activities they love. Our OL1000™ and Manafuse™ bone growth stimulators use clinically supported, noninvasive technologies designed to activate your body’s natural healing processes, whether you're recovering from a fresh fracture or managing a challenging non‑union.

Explore each device below to learn how they work, what makes them effective, and how Enovis supports you through insurance, setup, and treatment. For assistance, contact your sales representative or reach our Customer Care team at bonestim@enovis.com or 800.263.6004.

Insurance & Coverage

Will my insurance cover this device?

Most insurance plans, including Medicare and workers' compensation, may cover OL1000™ and Manafuse™ depending on your specific plan's criteria.

Do I need to handle pre-authorization myself?

No. Enovis will assist with pre-authorization and help manage your insurance claims on your behalf.

What happens if my insurance claim is denied?

If a claim is denied, Enovis will help guide you through the appeals process. Enovis will also discuss payment options with you if needed.

Important Safety Tips

Are there any usage precautions I should follow?

Yes. Do not use the device near strong magnetic fields or while smoking. Avoid using it near water or open wounds.

How do I maintain/clean the device?

Clean the device weekly with a damp cloth.

Is there anything else I should know about storage?

Yes keep the device out of reach of children and pets.

Are They Safe?

Are there side effects?

OL1000™ and Manafuse™ have no known significant adverse side effects.

Can I share my device or reuse it for a future treatment?

No. Both are single-patient use devices and should not be reused or shared with anyone else.

Are there any conditions where I should check with my doctor first?

Yes. Consult your doctor before use if you are pregnant or nursing, or if you have a pacemaker or other implantable device.

Tell us your story of recovery. Reach out to regen.marketing@enovis.com

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
Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. IGF-II receptor number is increased in TE-85 osteosarcoma cells by combined magnetic fields. J Bone Miner Res. 1995 May;10(5):812-9.
Charles Sfeir, DDS, PhD, Lawrence Ho, Bruce A. Doll, DDS, PhD, Kodi Azari, MD, and Jeffrey O. Hollinger, DDS, PhD. Fractrue Repair. Bone Regeneration and Repair, Biology and Clinical Applications. 2005, XII, 398p
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.
Wu N, Lee YC, Segina D, Murray H, Wilcox T, Boulanger L. The economic impact of US patients With fracture non-union, Orthopedic Research and Reviews, 2013; 5:21–33
[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).
NASS coverage reccomendations: https://www.spine.org/coverage
Linovitz, Raymond J., et al. "Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study." Spine 27.13 (2002): 1383-1388.
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.
[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).
Joel Russell, Sheila Sprague, Sam Harper, Michelle Green & Mohit Bhandari (2021) An early cost analysis of magnetic bone growth stimulation in England, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1920402
Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. Combined magnetic fields increased net calcium flux in bone cells. Calcified Tissue International. 1994;55(5):376-380. doi:10.1007/bf00299318
Aleem IS, Aleem I, Evaniew N, et al. Efficacy of electrical stimulators for Bone Healing: A meta-analysis of randomized sham-controlled trials. Scientific Reports. 2016;6(1). doi:10.1038/srep31724
Patient IFU Fracture
Cottrill E, Pennington Z, Ahmed AK, et al. The effect of electrical stimulation therapies on Spinal Fusion: A cross-disciplinary systematic review and meta-analysis of the preclinical and Clinical Data. Journal of Neurosurgery: Spine. 2019;32(1):106-126. doi:10.3171/2019.5.spine19465
Rami E, Rae S, John A. Increased spinal lumbar fusion with combined magnetic field (CMF) bone growth stimulation. Journal of Orthopedic Surgery and Techniques. 2020;3(1). doi:10.36959/453/526
Stippick TW, Sheller MR. Combined magnetic fields provide robust coverage for interbody and posterolateral lumbar spinal fusion sites. Medical & Biological Engineering & Computing. 2015;54(1):113-122. doi:10.1007/s11517-015-1319-2
Patient IFU Spine
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.
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.
Elsabeh R, Stegall R, Abrahams J (2020) Increased Spinal Lumbar Fusion with Combined Magnetic Field (CMF) Bone Growth Stimulation. J Orthop Surg Tech 3(1):84-91.
PMA P210016 1/17/2025
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Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73. doi:10.2106/00004623-199707000-00002
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OL1000 PMA 910066
https://www.spine.org/coverage
The only technology approved and with clinical evidence at 30 minutes per day.
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.
Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Acceleration of tibia and distal radius fracture healing in patients who smoke. Clin Orthop Relat Res. 1997;(337):198-207. doi:10.1097/00003086-199704000-00022 (need to get paper to determine if these were within 0-7 days)
Zura R, Mehta S, Della Rocca GJ, Jones J, Steen RG. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients. BMC Musculoskelet Disord. 2015;16:45. (Fresh and Intermediate <90 days is fresh, 0-90 days)
Nolte P, Anderson R, Strauss E, et al. Heal rate of metatarsal fractures: a propensity matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. 2016;47(11):2584-90. doi:10.1016/j.injury.2016.09.023
Gebauer D, Mayr E, Orthner E, Ryaby JP. Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med Biol. 2005;31(10):1391-402. doi:10.1016/j.ultrasmedbio.2005.06.002
Lerner A, Stein H, Soudry M. Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (exogen). Ultrasonics. 2004;42(1-9):915-7. doi:10.1016/j.ultras.2003.11.014
Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229. doi:10.1186/1471-2474-11-229

*This patient’s statement relates an account of their response to treatment. This account is genuine, typical and documented. However, this response does not provide any indication, guide, warranty or guarantee as to the response other people may have to the treatment. The response other individuals have to the treatment could be different. Responses to the treatment can and do vary. Not every response is the same.

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