Product Description; Intended Use - Ottobock 50K4-1 Agilium Freestep 2.0 Instrucciones De Uso

► Report each serious incident in connection with the product, in particu­
lar a worsening of the state of health, to the manufacturer and to the
relevant authority in your country.
► Please keep this document for your records.
These instructions for use contain important information for fitting and apply­
ing the 50K4-1 Agilium Freestep knee osteoarthritis brace.

2 Product description

2.1 Components (see Fig. 1)
Item: Description
1 Bars
3 Foot component
5 Allen head screws
Components not illustrated
Height adjuster
2.2 Design
The brace consists of a foot component and a lower leg component. These
components are connected via a freely movable brace ankle joint (sagittal
plane) (4).
The foot component consists of a foot component (3) that can be cut to size
and the foot stirrup (2).
The lower leg component consists of the brace ankle joint, two adjustable
bars (1) and the strap (6). 2 Allen head screws (5) are used to adjust the
lower leg component.

3 Intended use

3.1 Indications for use
The brace is intended exclusively for orthotic fittings of the lower limbs and
exclusively for contact with intact skin.
The brace must be used in accordance with the indications.
3.2 Indications
• Unicompartmental knee osteoarthritis
• Conditions/injuries requiring unicompartmental relief (e.g. post-operative
treatment following meniscus reconstruction or ligament injuries which
require unilateral relief)
The indication must be determined by the physician.
Item: Description
2 Foot stirrup
4 Brace ankle joint
6 Strap
Allen wrench
11