Limacorporate SMART SPACE 3D Mode D'emploi page 7

positioning of the 3D Positioner(s).
Device performances, where not differently indicated/communicated, are aimed to assist surgeon in
planning anatomic and reverse total shoulder arthroplasty and give the ability to translate the surgical plan
intraoperatively. The final design proposal is officially approved by the reference surgeon, who signs the final
revision of the Case Report prepared by the dedicated LimaCorporate engineer.
Design and development verification and validation are respectively performed with the aim to ensure that the
design and development outputs are compatible with the design inputs and to check that the designed product
meets the requirements for the specific application.
1.4. EXPECTED CLINICAL BENEFITS AND EXPECTED LIFETIME
Smart SPACE 3D Positioners System has the aim to allow the surgeon to perform a correct surgical procedure.
The 3D Positioner(s) has been designed to assist in the intraoperative positioning of shoulder components
used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are
identifiable on patient-specific pre-operative CT scans.
Although there have been no reports of improved patient-reported outcomes or implant survivorship in patients
who had computerized pre-operative planning utilized, compared to standard pre-operative planning, improved
glenoid component positioning is expected to result in the following theoretical benefits: improved functional
recovery, improved implant longevity, decreased rate of complications and decreased rate of revision surgery.
The definition of the expected lifetime is not applicable for the devices included in the Smart SPACE 3D
Positioners System since they are not implantable devices.
2. INTENDED PURPOSE, INDICATIONS, CONTRAINDICATIONS AND RISK FACTORS
The intended purpose of the Smart SPACE 3D Positioners System is to be used as surgical instruments
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 system is intended to be used for adult
patients that are candidates for shoulder replacement surgery and it is intended to be a surgical tool to transfer
a pre-operative plan into surgery. 3D Positioners are intended, by guiding the surgical instruments in some
steps of the orthopaedic surgical procedure, to prepare the bone to host the implantable components. 3D
Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the
surgeon. The model is intended to be used as a surgical planning aid.
These devices must be exclusively utilized by an orthopaedic surgeon who has a good knowledge of the
specific operative technique (shared on the Case Report).
2.1. INDICATIONS
Smart SPACE 3D Positioners System is indicated for use on adult patients that are candidates for primary
reverse and anatomic total shoulder arthroplasty.
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