AETOS Shoulder System - CONCELOC Glenoids

The AETOS Shoulder System CONCELOC Glenoids are cemented glenoid (shoulder socket) components intended for anatomic shoulder replacement in skeletally mature patients with degenerative joint disease. The system can be used with different humeral (upper arm bone) components in both anatomic configurations (for intact rotator cuffs) and reverse configurations (for massive rotator cuff tears with a functional deltoid muscle).

The subject device shares the same functional and technological characteristics as predicate devices via the same operational principles. It is made from the same materials and packaged and sterilized using identical methods as the predicates.

The document references ISO 13485 clauses (7.3 Design controls, 8.3 Nonconforming product, 8.5.2 Corrective action, 8.5.3 Preventative action) but does not cite specific consensus standards for performance testing. Nonclinical testing included loosening, pull-out, tensile and shear strength, fatigue, and pore morphology characterization.

Substantial equivalence is demonstrated because: (1) the subject and predicate devices have identical intended use and indications for use; (2) they share the same functional and technological characteristics through the same operational principles; and (3) they are manufactured from the same materials using the same packaging and sterilization methods. Nonclinical performance testing shows no adverse differences.