REDA -Bone Screws

These Instructions for Use do not replace the training, care and best available technology for the user. Therefore, we assume that the statutory provisions, standards and recommendations (e.g. from RKI or AKI) are known (see "Standards/References) and therefore, we restrict ourselves to the instructions and information for each product to be followed by the user, which are of importance for our products. The reasons for these instructions and risks that result from non-observance are listed in the statutory provisions and recommendations REDA Implants are design for Osteosynthesis procedures and degenerative skeletal dislocations.

Screws are intended for single use only and are not designed to be reused. All components are delivered NON-STERILE and must be appropriately prepared before first use. All packaging must be removed before preparation. The instruments may only be used for their intended purpose in the specified medical fields, with use being restricted to adequately trained and qualified personnel. The treating physician or user is responsible for selecting the right instrument(s) for the surgical task/application at hand as well as for their safe handling. This includes ensuring an adequate level of training, knowledge and experience.

GENERAL
Screws are used in bone fracture procedures as lag-screw or in combination with bone implant plates, for fixation of bone fragments

CORTICALIS SCREWS
Shell be used for the area of the Corticalis mainly at the diaphysis of larger bones The usage of Corticalis screws are designed for in-trafragmental compression in all types of bone fractures e.g. Metatarsal, metacarpal and proximal Phalanx. The Corticalis screw is also used in combination with mini fragment plates and tubular plates in the area of the hand and foot surgery.

SPONGIOSASCREWS
The screws shell be used if soft bones areas with thin corticalis in the area of metaphysis and epiphysis. The spongiosa screws are used for femoral neck fractures and tibia plateau fractures. The Spongiosa screw is also used in combination with mini fragment plates and tubular plates.

MALLEOLAR SCREWS
The screws shell be used for dense bone areas of metaphysis. E. g. distal humerus and trochanterial regions and at ankles.

CANNULATED SCREWS
The REDA cannulated screw, used with or without the washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot and. specifically, it is intended for:

• Fractures of carpals and metacarpals
• Carpal and metacarpal arthrodesis
• Small fragments of the hand and wrist
• Certain metatarsal phalangeal applications

HERBERT SCREW
The Herbert Compression Screws are intended for fixation of intra-articular and extra-articular fractures, avulsions, nonunions, and osteotomies of small bones and small bone fragments as well as arthrodesis of small joints.

Further the larger sizes of the Herbert screws are intended to use for fixation of bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. Reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodesis) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.

INTERFERENCE SREWS
Interference screws are intended to use in the reconstruction of Ligament ruptures for fixation of the ligament. Mainly the intended use is for cruciate ligament ruptures.