21 CFR 888.3695 — Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3695

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. It is indicated for use as a replacement of deficient humeral heads disabled by non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) or traumatic arthritis, in patients with an intact or reconstructable rotator cuff and an intact or sufficient native glenoid surface, to increase mobility, stability, and relieve pain.

Classification Rationale

Class II (special controls). The device is granted De Novo classification and is subject to general controls and the identified special controls to provide reasonable assurance of safety and effectiveness.

Product Codes