MD Orthopaedics Ponseti Lite FAB Instructions For Use

INSTRUCTION FOR USE
Ponseti® Lite Foot Abduction Bracing (FAB) System
Ponseti® Lite Boots
Ponseti® Lite Bar
Published: 2023
Intended Use & Indications
The Ponseti® Lite FAB is intended for use with children whose clubfoot is being corrected with the Ponseti Method of
treatment. The Ponseti® Lite Bar and Ponseti® Lite Boot comprise the Ponseti® Lite FAB System.
Ponseti® Lite FAB is for managing the advised width and orientation of the corrected clubfoot. The adjustable width bar
system utilizes multiple clip locations to accommodate patients throughout the treatment plan and easily clips on and off
the Ponseti® Lite Boots by means of "Quick Clip" system. Dorsiflexion and abduction are controlled with the geared quick
clip in 10 and 15 degrees. This system provides greater ease of use.
The Ponseti® Lite Foot Abduction Brace (FAB) is intended for the use in the Ponseti Method of treatment for the correction
of Congenital Talipes Equinovarus (CTEV) in infants and children less than or equal to eight years of age. The brace is
intended to prevent relapse (equinus and varus deformity of the heel).
Clinical Benefits:
The MD Orthopaedics Ponseti Lite FAB System retains the position of the anatomically corrected clubfoot deformity
until the health care provider indicate the device is no longer needed following successful manipulation and casting
as described by Dr. Ignacio Ponseti (the Ponseti Method), with a relatively low risk of relapse/recurrence and/or surgical
intervention.
Manufacturing Information
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654 USA
www.mdorthopaedics.com
1-877-766-7384
The manufacturer is not liable for cases of material damage or personal injury caused by incorrect handling or non-
compliance with instructions. In such cases, the warranty will be voided. Warranty of the Ponseti Lite FAB System is one
year under normal use. Normal use is defined as a single user following intended use.
MD Orthopaedics does not provide medical treatment, advice or recommendations about the risks and benefits of
medical treatment, including treatment that involves the use of MD Orthopaedics products. This information should be
provided solely by the health care provider treating your child. If you have questions about your child's treatment, it is
important for you to discuss those questions with the appropriate health care provider.
Cleaning Instructions
Ponseti® Lite Bar
Cleaned by using a mild detergent and damp cloth. Do not submerge.
Ponseti® Boots
Hand or machine wash using cool water, and mild detergent. A gentle washer cycle may be used. Air dry, do not place in
dryer. Do not use hot water when washing.
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