Artificial Shoulder Joint - Vietnam Registration 2403308ĐKLH/BYT-HTTB

The SMR Surface Regeneration System is indicated to replace part or all of the initial shoulder in patients with mature bone, where the humeral head and neck have sufficient bone mass to support the prosthetic components. The surgical surface regeneration heads are indicated to replace part or all of the initial shoulder when the rotator cuff is intact or reparable. Specific indications include: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Inflammatory degenerative joint diseases, such as rheumatoid arthritis; • Treatment of acute fractures of the humeral head where other fracture fixation techniques are not applicable; • Revision due to initial prosthesis failure (not applicable to the Subscapularis Preserving Technique; applicable only to the short SMR stem with non-cemented collar, if there is sufficient bone mass remaining); • Tear of the glenoid labrum (applicable only to the CTA head, not applicable to the Subscapularis Preserving Technique with the triangular group of muscles); • Degenerative joint disease, non-avascular necrosis: A1, A2 and B1 according to the Walch classification (applicable only to the SMR TT Hybrid Glenoid). The SMR Surface Regeneration Shoulder Joint is intended for use without cement.