Intended Use - Orthofix Galaxy Unyco System Anleitungsfaltblatt

Instruction leaflet - Please read prior to use
ORTHOFIX
®
GALAXY UNYCO SYSTEM
Orthofix Srl
Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy
Telephone +39 045 671 9000 - Fax +39 045 671 9380
0123
DESCRIPTION
The Orthofix Galaxy UNYCO System consists of a series of sterile kits that include UNYCO Cancellous Screws, Large Multiscrew Clamps for UNYCO Screws, Rods Ø 12mm, a
Radiolucent Foot Unit and specific application tools. External fixation systems are modular, therefore different frame configurations are possible. The Orthofix components in
the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. All Orthofix devices are intended for professional use
only. Surgeons who supervise the use of Orthofix devices must have full awareness of orthopaedic fixation procedures as well as adequate understanding of the philosophy of
the Orthofix modular system. To promote the proper use of its fixation system, and establish an effective promotional and training tool, Orthofix has developed several manuals
or CD-ROM's containing the relevant information (i. e. general philosophy, surgical application, etc.) called "Operative Techniques". These are available in several languages as a
complimentary service for surgeons who have adopted the Orthofix system. If you wish to receive a personal copy, please contact Orthofix or its local authorized representative,
with a description of the medical device to be used. They are also available in the Orthofix website and Orthofix mobile apps.

INTENDED USE

The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
INDICATIONS
Temporary stabilization of the tibia and foot in conditions and procedures, such as:
• comminuted open or closed tibial fractures
• polytrauma patient
• damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• intra-operative fracture reduction
• intermediate stabilization in staged surgery
• infected non-union pending second stage treatment bone-loss or other reconstructive procedures
The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not
indicated or available.
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