(106 days)
The Aequalis Resurfacing Head is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.
The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by:
- -Degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis. Primary and secondary necrosis of the humeral head.
Humeral head fracture. 1
The Aequalis Resurfacing Head is intended for uncemented use only.
The Aequalis Resurfacing Head is a humeral head resurfacing device. It requires less bone and cartilage removal, which makes it much more conservative than total joint implants. Revision or arthrodesis can be undertaken easily because the bone stock has been maintained with no loss of length. The main advantages of humeral head resurfacing are preservation of bone and the relatively simple surgical technique.
With the Aequalis Resurfacing Head the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury.
This document is a 510(k) premarket notification for a medical device called the "Aequalis Resurfacing Head," which is a humeral head resurfacing device. It is essentially a regulatory filing for a physical implant, not a software device or an AI/ML product.
Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "MRMC," "standalone performance," or "training set" as described in the prompt are not applicable to this document. These terms are typically used for evaluating the performance of diagnostic algorithms, AI/ML models, or software-as-a-medical-device (SaMD).
This 510(k) filing primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and manufacturing processes, rather than a performance study of the type described in the prompt.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.