S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem

Inclusion criteria

(Key)

• Both genders;
• Age ≥ 18 years old;
• Full skeletal maturity;
• Life expectancy over 5 years;
• Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;
• Good bone quality evaluated by the Investigator and the intraoperative evaluation;
• A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:

• Primary osteoarthritis;
• Secondary osteoarthritis;
• Post-traumatic arthritis;
• Rheumatoid arthritis;
• Avascular necrosis
• acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• cuff tear arthropathy (only in combination with CTA Heads);
• Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.

Exclusion criteria

(Key):

• Patient requiring revision shoulder arthroplasty;
• Osteoporosis with a history of non-traumatic fractures;
• Steroid injections within the previous 3 months;
• Contralateral shoulder replacement within the previous 3 months;
• Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
• Significant neurological or musculoskeletal disorders that may compromise functional recovery;
• Not recovered axillary nerve palsy;
• Non functioning deltoid muscle;
• Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
• Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.

These are key eligibility criteria, other eligibility criteria apply.