PLW · Acetabular Cup Orientation System
Orthopedic · 21 CFR 888.3350 · Class 2
Overview
| Product Code | PLW |
|---|---|
| Device Name | Acetabular Cup Orientation System |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
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).
Classification Rationale
Class II.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150780 | Acetabular Cup Orientation System | Materialise NV | Oct 27, 2015 | SESE |
Top Applicants
- Materialise NV — 1 clearance
