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.
Cleared Devices (0)
No cleared devices on record.
