(49 days)
Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component)may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.
OTI Modular Shoulder System (Hemi humeral component)
Given the provided text, there is no information regarding acceptance criteria, device performance, or any studies proving the device meets specific criteria.
The document is a 510(k) clearance letter from the FDA, indicating that the OTI Modular Shoulder System has been found substantially equivalent to a predicate device. It specifies the product code, regulatory class, and indications for use.
Therefore, I cannot provide answers to your specific questions as the relevant information is not present in the given text.
§ 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.