Medical Monofilament Manufacturing
Precision screening that helps prevent diabetic amputations
The gold standard 5.07 monofilament. Patented, calibrated daily, trusted by clinicians since 1999.
FDA 510(k) Cleared
Only U.S. manufacturer
Made in the U.S.A.
All components domestic
Patented Process
Automated precision manufacturing
Our Products
Monofilaments for all needs
Choose your handle type and pack size. Every unit calibrated to a 10 gram force range, ±1.5 g.
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Kaiser, DOD & VA handles
Shop all →Early detection saves limbs
Of non-traumatic amputations are caused by diabetic neuropathy and sensory loss.
Of diabetic amputations are preventable with proper screening and foot care.
Americans currently living with diabetes. A new diagnosis occurs every 17 seconds.
How Monofilaments Work
The 5.07/10g monofilament test checks for loss of protective sensation in the feet, one of the earliest signs of diabetic peripheral neuropathy. It takes about a minute and is recommended by the American Diabetes Association for every patient with diabetes at least once a year, and more frequently for high-risk patients at the doctor's discretion.
1. Touch the filament to the foot
Use a smooth motion to press the filament against the four test sites on each of the patient's feet, bending it for 1 to 2 seconds.
2. Record the response
Mark (+) if the patient feels sensation, (-) if they do not. Patient keeps eyes closed throughout.
3. Dispose after single use
Each monofilament is single-use per FDA guideline, ensuring a consistent 10 gram force range, ±1.5 g, for every screening.
Patented Process
Automated precision,
calibrated daily
Our patented automated manufacturing line removes human variability from every filament we make in Plymouth, MA.
- Precision inline sensors on every production run
- Daily gram-scale calibration to the 10g standard
- Visual inspection before every unit ships
About Medical Monofilament
The only FDA-cleared monofilament manufacturer in the U.S.
Founded in Plymouth, Massachusetts in 1999, Medical Monofilament has spent more than 27 years perfecting a single critical tool: the 5.07 monofilament used to screen for diabetic peripheral neuropathy. Our patented automated manufacturing process calibrates every filament to deliver a 10 gram force range, ±1.5 g, the clinical threshold that determines a patient's risk for ulceration and amputation. No other manufacturer in the country has achieved 510(k) FDA clearance for this device.
Our full storyCommon Questions
Monofilament FAQ
What is a monofilament?
A monofilament is a single strand of polymer fiber used as a sensory testing tool. In diabetic care, the 5.07 monofilament is the clinical standard for detecting loss of protective sensation (LOPS) in the feet. When pressed against the skin with enough force to bend the filament, it delivers a 10 gram (±1.5 g) touch stimulus. A patient who cannot feel that stimulus has lost protective sensation and is at elevated risk for foot ulceration and amputation.
Who should be screened with a monofilament?
All patients with diabetes should receive an annual foot sensory exam using a monofilament. Higher-risk patients, such as those with a history of foot ulcers, poor glycemic control, or peripheral artery disease, may warrant more frequent screening. The test is also used in neurology, physical therapy, and any clinical setting assessing peripheral nerve function.
How does the monofilament test work?
Hold the monofilament by its handle and press the tip against the plantar surface of the patient's foot until the filament bends, holding for 1-2 seconds. The patient keeps their eyes closed and says "yes" when they feel contact. Mark (+) for sensation felt and (-) for no sensation at each of the four test sites on each foot.
Are monofilaments reusable?
No. Per FDA guidelines, monofilaments are single-use devices: one screening per unit before disposal. Repeated use degrades the polymer fiber, causing the delivered force to drift below the 10-gram threshold and making the test clinically unreliable.
Are your monofilaments FDA cleared?
Yes. Medical Monofilament has achieved 510(k) clearance from the FDA, the only monofilament manufacturer in the United States to hold this designation. Many monofilaments sold in the U.S. have not undergone this regulatory review. Monofilaments are FDA Class I, single-use medical devices, and single use prevents cross-contamination between patients.
What does "calibrated" mean?
A calibrated monofilament has been verified to deliver a 10 gram force range, ±1.5 g, when bent to the point of flexion. We calibrate production daily using gram scales and employ precision inline sensors and visual inspection systems throughout our automated process.
How long do monofilaments last?
Our monofilaments carry a 2-year shelf life from the date of manufacture, per FDA standards. All products ship with at least 22 months remaining.
Get in Touch
Questions? We're here.
Whether you're placing your first order, looking for distributor pricing, or have a clinical question, our team is ready to help.