IMPLANT DESCRIPTION FIXATION MATERIAL MATERIAL Fixators and clamps: Alluminium alloy 7012 - Stainless steel AISI 316LVM Pins: Stainless steel AISI 316LVM ISO 5832-1 PRODUCT IDENTIFICATION TRACEABILITY To assure the traceability, Smart System devices are idendified as follows: Fixators Batch + Serial number + Part number Clamps Batch + Part number Fixation Material Batch + Diameter + Length STERILIZATION Smart System device is supplied NON STERILE. Mikai advises using sterilization with autoclave (saturated steam) with the following parameters: Temperature 135° Mikai does not advise using EtO method of sterilization nor other cold sterilization methods Clamps and fixation materials are supplied STERILE. Produced by Mikai S.p.A. Headquarters: Via P Gobetti 56r - 16145 Genova Manufacturing facility: Via Canestrello 2 - 36050 Monteviale (VI) Mikai S.p.A. conforms to ISO 9001:2000 and ISO 13488

CLINICAL CASES Smart System is a modular external fixation system indicated for pathologies of the small hand segments, such as metacarpal and phalangial. The simplicity of use along with the lightweight fixator body allow for an effective synthesis and the possibility to carry out corrections, even in a post operative phase, in bony segments where the error margin must be next to zero. Another important characteristic of the Smart System is the possibility to insert screws on various planes, as required, without having subsequent difficulties in positioning of the clamps. The lengthener is comprised...