Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A ROM brace (range-of-motion brace) is a hinged limb brace whose joint can be locked or limited to a set angle, so a joint can move through a controlled arc while it heals after injury or surgery. This page is for clinic staff, buyers and students who need to know what the device is, how its hinge limits work, how the FDA classifies it, and what manufacturers say about safe handling. Who uses it: orthopaedic and physical-therapy clinics that fit it on the order of a licensed clinician, and the patients they treat.
What a ROM brace is
A ROM brace is a limb orthosis with an adjustable hinge. The hinge has stops that limit how far the joint can straighten (extension) and bend (flexion), and many designs can also lock the joint at a fixed angle. The best-known type is the hinged knee brace used after ligament, cartilage or fracture treatment. One manufacturer’s instructions describe its knee model as intended for “controlled range-of-motion for post-traumatic, post-surgical repair of the knee” (Thuasne ROM-R V.2 instruction guide, checked 2026-10-30).
How the hinge and stops work
The brace has rigid side bars (uprights) joined by hinges at the joint, with straps and padding that hold it to the limb. The stops are set on the hinge itself. Two manufacturers’ instructions show how this works in practice, and the details differ by model.
- Extension and flexion stops. Separate settings limit straightening and bending. On the ROM-R V.2 the extension stop is set from 0 to 105 degrees and the flexion stop from 0 to 120 degrees, both in 15-degree steps.
- Locking. The ROM-R V.2 has a drop lock set at 0 degrees that can be locked in 15-degree increments from 0 to 105 degrees. On the Breg WeeRom Knee the hinge can be locked at -10, 0, 10, 20, 30 or 40 degrees, independently of the range-of-motion settings.
- Both sides must match. The WeeRom instructions say to adjust the opposite hinge to match the first hinge’s setting, and describe this step as vital to ensure proper knee protection.
- Tamper resistance. The ROM-R V.2 ships with zip ties to prevent the patient from changing the stop settings.
Types and variants
| Model (one manufacturer’s example) | Stated intended use | Key difference |
|---|---|---|
| Thuasne/Townsend ROM-R V.2 knee brace | Controlled range of motion of the knee (maker wording: post-traumatic, post-surgical) | Extension stop 0-105 degrees and flexion stop 0-120 degrees in 15-degree steps; drop lock |
| Breg WeeRom Knee (paediatric) | Locked or limited motion control of the knee during rehabilitation after operative procedures or knee injury | Separate extension and flexion limit buttons that lock automatically; hinge lock at -10 to 40 degrees |
Other joints, such as the elbow and ankle, also have hinged range-of-motion designs. Related CASRAI pages cover neighbouring devices: the CAM boot, the hip brace and the knee-ankle-foot orthosis.
Settings two manufacturers list
| Feature | ROM-R V.2 (Thuasne/Townsend) | WeeRom Knee (Breg) |
|---|---|---|
| Extension limit | 0-105 degrees, 15-degree steps | Separate extension limit button |
| Flexion limit | 0-120 degrees, 15-degree steps | Separate flexion limit button |
| Hinge lock | Drop lock at 0 degrees, lockable 0-105 degrees in 15-degree steps | -10, 0, 10, 20, 30 or 40 degrees |
| Single patient / use limit | Single patient use | Not for a second patient; not for use beyond 180 days |
These are model-specific figures from each maker’s instructions, not a standard for all ROM braces. The settings a patient uses are chosen by the treating clinician.
How regulators classify it
In the United States a ROM brace falls under the limb orthosis regulation, 21 CFR 890.3475, which defines a limb orthosis (brace) as a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. It is Class I (general controls), exempt from premarket notification (510(k)) subject to the limits in 21 CFR 890.9, and exempt from the quality system regulation except for records and complaint files (820.35). The openFDA classification database lists product code ITQ, “Joint, Knee, External Brace”, and IQI, “Orthosis, Limb Brace”, both Class 1 and GMP-exempt, with related codes for ankle (ITW), hip (ITS) and arm support (IOY).
Who decides and what rules out use
The two manufacturers’ instructions state who decides and what rules out use, rather than offering a selection checklist.
- A licensed professional prescribes and fits it. The ROM-R V.2 guide says the brace is prescribed and fitted by a licensed medical professional. The WeeRom instructions say it is sold by or on order of a physician.
- Contraindications. Both instructions list unstable fractures and fractures of the proximal femur or distal tibia or fibula as contraindications.
Safe use and handling basics
- Fit: the ROM-R V.2 guide says to align the hinge centre with the knee centre; the uprights can be contoured and their length adjusted.
- The ROM-R V.2 guide says the patient should consult the medical professional before making any adjustments.
- Care for the ROM-R V.2: remove the pads, hand wash in cold water with mild detergent, do not machine wash or tumble dry, and do not immerse the hinges and uprights.
- The WeeRom instructions say not to leave the brace in a car above 150 F (65 C), and to report serious incidents to the manufacturer and the competent authority.
- The WeeRom instructions also state the brace is not intended to prevent injuries or reduce the risk of reinjury.
Common mistakes
- Mismatched hinges. The WeeRom instructions call matching both hinges’ settings vital.
- Letting the wearer change the stops without the clinician. The tamper-resistance zip ties on the ROM-R V.2 exist for this reason.
- Reusing a single-patient brace on another patient, or using the WeeRom beyond 180 days.
- Treating one maker’s range figures as universal across brands.
FAQ
What does ROM stand for in a ROM brace?
Range of motion. The name refers to the brace’s adjustable hinge, which limits how far the joint can straighten and bend.
Is a ROM brace a medical device?
Yes. In the US it is a limb orthosis under 21 CFR 890.3475, Class I and exempt from 510(k) premarket notification, subject to 21 CFR 890.9.
Can the wearer change the hinge settings?
Manufacturers say the patient should consult the licensed professional before adjusting, and at least one model ships with zip ties to stop tampering.
See also the durable medical equipment list and the crutches, canes and ankle braces guide.
Sources
- 21 CFR 890.3475, Limb orthosis, law.cornell.edu, checked 2026-10-30.
- openFDA device classification API, regulation number 890.3475, api.fda.gov, checked 2026-10-30.
- Thuasne/Townsend ROM-R V.2 Medical Professional Instruction Guide (L-0116 Rev B), thuasneusa.com, checked 2026-10-30.
- Breg WeeRom Knee instructions for use AW-CP020283 Rev C 10/23, breg.com, checked 2026-10-30.
