Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3500](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3500) → KFX — Assembly, Thigh/Knee/Shank/Ankle/Foot, External

# KFX · Assembly, Thigh/Knee/Shank/Ankle/Foot, External

_Physical Medicine · 21 CFR 890.3500 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX

## Overview

- **Product Code:** KFX
- **Device Name:** Assembly, Thigh/Knee/Shank/Ankle/Foot, External
- **Regulation:** [21 CFR 890.3500](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3500)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932184](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K932184.md) | STERILE LEMAITRE GLOW 'N TELL TAPE | Vascutech, Inc. | Jul 22, 1993 | SESE |
| [K833868](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K833868.md) | IPOS G.L.P. SYSTEM | Ipos Luneburg | Nov 28, 1983 | SESE |
| [K830285](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K830285.md) | REGNELL HYDRAULIC FEMORAL PROTHESIS | Besco Financial Service | Mar 9, 1983 | SESE |
| [K822240](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K822240.md) | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | American Mcgaw | Dec 30, 1982 | SESE |

## Top Applicants

- American Mcgaw — 1 clearance
- Besco Financial Service — 1 clearance
- Ipos Luneburg — 1 clearance
- Vascutech, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX)

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