MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
Device Facts
| Record ID | K861988 |
|---|---|
| Device Name | MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY |
| Applicant | Protek, Inc. |
| Product Code | JDI · Orthopedic |
| Decision Date | Feb 11, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
