Manafuse




















Manafuse®
The Manafuse product has been acquired by Enovis from ManaMed. While it currently retains the ManaMed branding during this transition period, all updates and support will be provided by Enovis. If you have been prescribed a Manafuse product, an Enovis representative will be in touch with you directly.
The Manafuse™ Bone Growth Stimulator is a portable, battery-powered medical device indicated for daily use in the noninvasive treatment of indicated* fresh fractures and fracture nonunion. The stimulator emits a Low Intensity Pulsed Ultrasound (LIPUS) signal that assists in activating the body’s natural healing process.
The Manafuse Bone Growth Stimulator was designed with the following features:
- Lightweight and comfortable
- Easy to use and noninvasive
- Worn for 20 minutes once per day for up to 343 days
- Tracks daily treatment compliance
Manafuse LIPUS technology has been shown to offer statistically significant improvement in fracture healing when used as indicated. Clinical studies reported success rates as high as 86%.3
Contact Enovis:
Find a sales representative.
Contact Customer Care at: (800) 263-6004
*PMA# P210016
- Overview
- Documents
- References
Indications:
The ManaFuse system is indicated for the non-invasive treatment of established nonunions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
Contraindications:
There are no known contraindications.
Warnings:
The safety and effectiveness of this device has not been established for:
- Fractures with post-reduction displacement of more than 50% (i.e., fractures in which the opposing broken bone ends are out of alignment by more than one half of the width of the bone).
- Pathological fractures due to bone pathology or malignancy (fractures due to disease).
- Pregnant or nursing women.
- Individuals with thrombophlebitis (blood clot in a vein), vascular insufficient (poor blood supply), abnormal skin sensitivity (very sensitive skin), sensory paralysis (lack of sensation), alcoholism and/or nutritional deficiency.
- Individuals receiving steroid, anticoagulant, prescription non-steroidal antiinflammatory, calcium channel blocker and/or diphosphonate therapy. Individuals using these therapies were excluded from the studies because of the possible effects of these therapies on bone metabolism.
- Treatment of non-unions or fractures of the vertebra or the skull.
- Individuals lacking skeletal maturity.
- Fresh fracture locations other than the distal radius (end of the large bone in the forearm) or tibial diaphysis (middle 80% of the large bone in your lower leg).
- Fresh fractures that are open Grade II or III (fractures with large wounds) or that require surgical intervention with internal or external fixation (screws and/or plates used to hold your broken bones in place) or that are not sufficiently stable for closed reduction (manipulation of the fracture without surgery) and cast immobilization (cast treatment).
Precautions:
- The ManaFuse device will not correct or alter post-reduction (when your fracture is initially set and placed in a cast) aspects of a fracture such as displacement, angulation or malalignment.
- The transducer, strap and gel are not sterile and should not be placed on an open wound.
- The operation of active, implantable devices, such as cardiac pacemakers, may be adversely affected by close exposure to the ManaFuse device. The physician should advise the patient, or other person in close proximity during treatment, to be evaluated by their attending cardiologist or implant physician before starting treatment with the ManaFuse device.
- The cords pose a risk for strangulation. Keep out of reach of children.
- Cell phones, televisions, and other devices using radio frequency identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic article surveillance), near-field communications (NFC) systems, wireless power transfer and unique medical emitters such as electrocautery, electrosurgical 12 units, and diathermy equipment may cause interference. Don’t use the ManaFuse device closer than 15 cm (6 inches) from these electromagnetic (EM) emitters.
- The safety and effectiveness of the ManaFuse device for use of more than one daily 20-minute treatment period has not been studied.
- Check the transducer and the transducer cord before starting treatment. If there are any signs of damage, do not use the device and call Customer Service at 800-263-6004.
- When choosing a treatment site, ensure that the site selected allows for full contact of the transducer face with the skin. Failure to do so may result in the transducer being only partially coupled to the skin. This may reduce the effectiveness of the ManaFuse device in treating the fracture.
- Only the region of the fracture within the effective radiating area (3.88 +/- 20% square cm (cm2) ) of the transducer is likely to benefit from the ManaFuse device’s treatment. Therefore, the physician and patient should take care in appropriately placing of the device over the fracture site.
- Placement of the transducer directly over internal fixation may result in the treatment signal being partially or fully blocked and may reduce the effectiveness of the ManaFuse device in treating the fracture.
- When choosing a treatment site, the transducer shall be positioned such that the ultrasound beam is not impeded by any internal fixation which is directly in line with the fracture site (i.e., not directly over metal plating). This may require placement of the transducer on the opposite side of the limb or perpendicular to the fracture line. Correct placement should be confirmed using radiographic and/or anatomical markers by a health care provider during the fitting of the device. The ManaFuse device’s site of application should be marked onto the patient’s skin with an indelible marker to guide future transducer placements.
- The ManaFuse device is NOT safe for use in a Magnetic Resonance (MR) environment and may be damaged or present a projectile hazard in that environment.
CAUTION: Federal law (U.S.A. and Canada) restricts this device to sale, distribution or use by or on the order of a physician.
- Heckman JD, Ryaby JP, McCabe J, Frey J, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34. doi:10.2106/00004623-199401000-00004 (0-7 days)
- 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(0-7 days)
- 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
- Baumhauer Phillips M.Baumhauer J, Sprague S.Zolten J. Use of Combine Magnetic Field Treatment for Fracture Nonunion. J Long Term Eff Med Implants. 2016: 26(3): 277-284.doi 10.1615/JLongtermEffMedimplants.206016818. PMID:28134611.
- 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
- PMA P210016 1/17/2025