Name And Address Of The Manufacturer; Description Of The Product; Intended Use And Reasonably Foreseeable Misuse; Sterilization State And Method - MD Mitchell Ponseti Gebrauchsanweisung

1.6.5 Name and address of the manufacturer

The following natural or legal person makes the device, to which this user manual applies, suitable for use within the European Union and
is the manufacturer of the device:
The Mitchell Ponseti® Ankle Foot Orthotic and Ponseti® Abduction Brace are manufactured by:
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654 USA
www.mdorthopaedics.com
1-877-766-7384

2 DESCRIPTION OF THE PRODUCT

2.1 Intended Use and Reasonably Foreseeable Misuse

The Mitchell Ponseti® Ankle Foot Orthotic is a Class I medical device intended for use only on children whose clubfoot is being
corrected with the Ponseti Method of treatment, and only as prescribed by a physician fully trained in the Ponseti Method.
The Mitchell Ponseti® Ankle Foot Orthotic shall not be used without prescription by a physician trained in the Ponseti method and is
to be used only as prescribed.
The Mitchell Ponseti® Ankle Foot Orthotic shall not be used to treat any other orthopedic condition other than clubfoot unless
otherwise prescribed by the physician or orthotist.
The Mitchell Ponseti® Ankle Foot Orthotic shall be used with the following original accessories and components only:
• Ponseti® Adjustable Bar
Available with either 10 or 15 degrees of dorsiflexion.
o
• Mitchell Spring Assist Dobbs Bar
• Pressure Saddles
• Bar Covers
Education on proper brace application and troubleshooting for skin issues is critical to ensure your child's clubfoot correction is
effective. DO NOT USE this device without first being trained by your physician or clinical team. Contact Customer Support for
assistance in locating training resources.

2.2 Sterilization State and Method

Not applicable, as the Mitchell Ponseti® Ankle Foot Orthotic is not a sterile product.

2.3 Summary of Safety and Clinical Performance

The Mitchell Ponseti® Ankle Foot Orthotic is a Class I, non-implantable device. Therefore, a Summary of Safety and Clinical Performance
is not required.

2.4 Technical Characteristics

The Mitchell Ponseti® AFO was designed with a soft, contoured elastomeric liner to cushion and hold the child's foot in place. Straps
and a body made from a ductile synthetic suede conform to the shape of the foot for added comfort and stability. The AFO has openings
on the side to add ventilation and keep the foot cool, and a porthole in the heel socket to help guide proper placement of the heel
in the AFO.
NOTE: Socks are required to eliminate skin contact with product.
The Ponseti® Abduction Bar was designed to be easily adjustable to the shoulder width of the child. The Quick Release clips make it easy
for the bar to be attached and removed from the AFOs as needed for clothing and diaper changes, etc.
The length of the foot should be measured from the heel to tip of big toe. Do not add growing room as this is allowed for in the
table below.
The AFOs on Preemie 1, 2 are permanently attached to an adjustable bar.
Document MD-124 3