SELF-ALIGNING ACETABULAR COMPONENT
Device Facts
| Record ID | K831792 |
|---|---|
| Device Name | SELF-ALIGNING ACETABULAR COMPONENT |
| Applicant | Endomedics, Inc. |
| Product Code | JDL · Orthopedic |
| Decision Date | Sep 20, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3320 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
