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 890.3475](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3475) → ITM — Cage, Knee

# ITM · Cage, Knee

_Physical Medicine · 21 CFR 890.3475 · Class 1_

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

## Overview

- **Product Code:** ITM
- **Device Name:** Cage, Knee
- **Regulation:** [21 CFR 890.3475](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3475)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **GMP exempt:** yes

## Identification

A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832742](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITM/K832742.md) | EXTENSION CONTROL KNEE ORTHOSIS | Orthomedics | Sep 20, 1983 | SESE |
| [K812064](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITM/K812064.md) | POLI-AXIAL KNEE CAGE | Generation II Orthotics, Inc. | Aug 13, 1981 | SESE |
| [K770900](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITM/K770900.md) | CAST BRWM, FRACTURE | Chase Mfg. Co. | Jul 21, 1977 | SESE |
| [K770899](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITM/K770899.md) | FRACTURE CAST BRACE, POLY | Chase Mfg. Co. | Jul 21, 1977 | SESE |
| [K760573](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITM/K760573.md) | IMPROVED KNEE DRESSING | Richard'S Medical Equip., Inc. | Oct 5, 1976 | SESE |

## Top Applicants

- Chase Mfg. Co. — 2 clearances
- Generation II Orthotics, Inc. — 1 clearance
- Orthomedics — 1 clearance
- Richard'S Medical Equip., Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com