Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3320](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3320) → LTO — Spacer, Cement

# LTO · Spacer, Cement

_Orthopedic · 21 CFR 888.3320 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LTO

## Overview

- **Product Code:** LTO
- **Device Name:** Spacer, Cement
- **Regulation:** [21 CFR 888.3320](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3320)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **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._

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LTO](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LTO)

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