SMART SYSTEM

Product catalog summary

Product Overview
The Smart System is a modular external fixation system designed for small hand segments, such as metacarpal and phalangeal bones. It is lightweight and allows for effective synthesis and corrections post-operatively. The system includes a lengthener with a millimeter graduated bar for accurate measurement and an articular fixator for correcting rigidities with micrometric regulation.

Components and Part Numbers

Smart System - Lengthener: MMC-5002201
Smart System - Articular Fixator: MMC-5002202
Single clamp Ø up to 2 mm: MMC-5002210ST
Dual monolateral clamp: MMC-5002212ST
Instrumentation includes various wrenches and guide cannulas with specific part numbers.

Fixation Material
Self-drilling cortical screws are available in various lengths, all with a diameter of 2 mm and a thread length of 10 mm. Materials used include aluminum alloy 7012 and stainless steel AISI 316LVM.

Sterilization and Traceability
The Smart System is supplied non-sterile and should be sterilized using an autoclave at 135°C, 2 atm pressure for 45 minutes. Clamps and fixation materials are supplied sterile. Traceability is ensured through batch and serial numbers.

Indications for Use
The system is indicated for fractures, pseudoarthrosis, infected pseudoarthrosis, corrective osteotomies, congenital deformities, articular rigidities, lengthening, and fractures with severe soft tissue lesions.

Clinical Cases

Articular Rigidities: A 25-year-old patient with stiffened flexion of the third finger underwent surgery with an articulated fixator, achieving extension in 45 days.
Lengthening: A four-year-old patient with congenital multidigit hypoplasia underwent plastic surgery and lengthening of the second metacarpal bone using the Callotosi technique.

Manufacturer Information
Produced by Mikai S.p.A., the company conforms to ISO 9001:2000 and ISO 13488 standards. Contact details for headquarters and manufacturing facilities are provided.

Catalog excerpts

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

Open the catalog to page 1

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...

Open the catalog to page 2

All MIKAI catalogs and technical brochures

Archived catalogs

BLUE SHARK - 2014
2 Pages