Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3530](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3530) → LGE — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing

# LGE · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing

_Orthopedic · 21 CFR 888.3530 · Class 2_

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

## Overview

- **Product Code:** LGE
- **Device Name:** Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
- **Regulation:** [21 CFR 888.3530](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3530)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee 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 component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K992346](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LGE/K992346.md) | KINEMATIC II ROTATING HINGE KNEE | Howmedica Osteonics Corp. | Aug 12, 1999 | SESE |
| [K811630](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LGE/K811630.md) | KINEMATIC ROTATING HINGE TOTAL KNEE PR. | Howmedica Corp. | Jul 1, 1981 | SESE |

## Top Applicants

- Howmedica Osteonics Corp. — 1 clearance
- Howmedica Corp. — 1 clearance

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

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