§ 888.3695 Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis.

(a) Identification. A shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials such, as pyrolytic carbon, and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of improvement of shoulder function and reduction of symptoms, including pain and function, for the indications for use; and (ii) Evaluation of adverse events, including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of the mechanical function (mechanical fatigue strength including evaluation of fretting and corrosion, static mechanical strength, modular component disassembly strength, and wear analysis) and durability of the implant; and (ii) Evaluation of worst-case device range of motion. (3) All patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Labeling must include the following: (i) Validated methods and instructions for reprocessing of any reusable components; and (ii) A shelf life.