MyCRO Band Orthosis, Cranial

No FDA recalls found in the data synced 22 Oct 2026.

Full name

MyCRO Band

510(k) Number

K201426 ↗

FDA product code

MVA

Device class

Class II

Regulation

21 CFR Part 882.5970

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

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See all devices from Otto Bock HealthCare LP →

• What types of infant head deformities is the MyCRO Band designed to address and how does it work?

  The MyCRO Band is specifically designed to correct positioning-related head deformities in infants, such as plagiocephaly or brachycephaly, caused by prolonged pressure during early development. It uses custom-fabricated contact and growth zones to guide cranial development by gently limiting expansion in targeted areas while allowing natural shaping in unaffected regions. The device is tailored to each infant’s unique head shape and is intended to be worn under professional supervision to encourage proper cranial growth.

• Is the MyCRO Band reusable or single-use, and how is it supplied?

  The MyCRO Band is supplied as a single-use device, meaning it is custom-fabricated for each patient and not intended for reuse. It is created via 3D printing and includes an adaptable closure system to ensure a secure, personalized fit. Each unit is designed for one-time use under the guidance of a Certified Prosthetist-Orthotist (CPO), cranial specialist, or pediatrician.

• Who should prescribe or fit the MyCRO Band, and what level of expertise is required?

  The MyCRO Band is intended for use only under the supervision of a Certified Prosthetist-Orthotist (CPO), a cranial specialist, or a pediatrician. These professionals assess the infant’s condition, customize the device to fit their head shape, and monitor its use to ensure proper cranial development. The device is not self-applicable and requires clinical oversight for safe and effective application.

• Are there different sizes or models of the MyCRO Band, and how is the fit adjusted?

  The MyCRO Band is custom-fabricated for each patient, meaning there are no standardized sizes or models. The device is tailored to the infant’s specific head measurements and deformity pattern, with an adaptable closure system allowing for precise adjustments to ensure a secure and comfortable fit. This personalized approach ensures optimal contact pressure in targeted growth zones while accommodating natural cranial development.

• What is the regulatory pathway for the MyCRO Band, and how is its safety and performance ensured?

  The MyCRO Band follows the FDA 510(k) clearance pathway, classified as a Class II medical device under product code MVA (Orthotics, Cranial). It was determined substantially equivalent to a predicate device through a traditional review process, with input from the Neurology Advisory Committee. While the device is not explicitly labeled as sterile or MRI-safe in the regulatory submission, its design and fabrication standards align with FDA requirements for orthotic devices intended for pediatric cranial correction.