LTO · Spacer, Cement
Orthopedic · 21 CFR 888.3320 · Class 3
Overview
| Product Code | LTO |
|---|---|
| Device Name | Spacer, Cement |
| Regulation | 21 CFR 888.3320 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
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).
Classification Rationale
Class III.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
