TRIAXIAL
Device Facts
| Record ID | K802348 |
|---|---|
| Device Name | TRIAXIAL |
| Applicant | Johnson & Johnson Professionals, Inc. |
| Product Code | JDB · Orthopedic |
| Decision Date | Feb 23, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
