S-ROM POLY-DIAL CONSTRAINED LINER
Device Facts
| Record ID | P960054 |
|---|---|
| Device Name | S-ROM POLY-DIAL CONSTRAINED LINER |
| Applicant | Depuy, A Johnson & Johnson Co. |
| Product Code | KWZ · Orthopedic |
| Decision Date | Jun 19, 1997 |
| Decision | APRL |
| Regulation | 21 CFR 888.3310 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
