Product Information - Limacorporate SMART SPACE 3D Mode D'emploi

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INSTRUCTIONS FOR USE – SMART SPACE 3D POSITIONERS SYSTEM
Before using a LimaCorporate product, the surgeon should carefully review the following recommendations,
warnings and instructions, as well as the available product-specific information (e.g.: Case Report).

1. PRODUCT INFORMATION

The devices included in the Smart SPACE 3D Positioners System are custom-made devices provided
by LimaCorporate, specifically designed on or representing the patient anatomy. They are designed in
accordance with a written prescription of a person authorized by national law by virtue of that person's
professional qualifications which gives, under that person's responsibility, specific design characteristics, and
is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
Smart SPACE 3D Positioners System includes two elements: the 3D Positioners (patient-specific instruments)
and the 3D Anatomical Models (patient-specific anatomical models) designed by means of the Smart SPACE
Shoulder Planner. Smart SPACE Shoulder Planner is a stand-alone software intended to be used as a pre-
surgical planner for orthopaedic shoulder surgery.
Smart SPACE 3D Positioners System is intended to be used for adult patients that are candidates for shoulder
replacement surgery and its aim is to simplify and improve the performance of surgery and the placement
of the implantable medical device, personalizing the surgical technique on single patient base. The devices
included in the Smart SPACE 3D Positioners System are designed for a single patient. Their use is described
in the Case Report related to the specific case.
Smart SPACE 3D Positioners System assists surgeon in planning anatomic and reverse total shoulder
arthroplasty and gives the ability to translate the surgical plan intraoperatively. It is intended to be used in
combination with components/instruments belonging to the LimaCorporate SMR Shoulder System and SMR
TT Hybrid Glenoid System. Devices of the SMR Shoulder and SMR TT Hybrid Glenoid systems cannot be
used in combination with devices of other manufacturers. Smart SPACE 3D Positioners System should not be
used with components from other systems or associated to other instruments.
Smart SPACE Shoulder Planner is intended to be used by an orthopedic surgeon, with clinical experience
in shoulder replacement surgery to make decisions regarding implant position, orientation and sizing. For
detailed information on it, please refer to the Smart SPACE Shoulder Planner Instructions For Use.
1.1. MATERIALS
The devices included in the Smart SPACE 3D Positioners System are made in Polyamide (PA 2200). Some
patients may be hypersensitive or allergic to the devices' materials; this should be appropriately considered
by the surgeon.
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