Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3590](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3590) → HSH — Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

# HSH · Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

_Orthopedic · 21 CFR 888.3590 · Class 2_

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

## Overview

- **Product Code:** HSH
- **Device Name:** Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- **Regulation:** [21 CFR 888.3590](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3590)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

## Classification Rationale

Class II.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K073233](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K073233.md) | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Advanced Bio-Surfaces, Inc. | Jan 28, 2008 | SESE |
| [K053094](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K053094.md) | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 | Advanced Bio-Surfaces, Inc. | Feb 6, 2006 | SESE |
| [K033242](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K033242.md) | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Imaging Therapeutics, Inc. | Dec 31, 2003 | SESE |
| [K022779](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K022779.md) | OTI UNICONDULAR INTERPOSITIONAL SPACER | Osteoimplant Technology, Inc. | Nov 20, 2002 | SESE |
| [K003269](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K003269.md) | UNICONDYLAR INTERPOSITIONAL SPACER | Sulzer Orthopedics, Inc. | Jan 4, 2001 | SESE |

## Top Applicants

- Advanced Bio-Surfaces, Inc. — 2 clearances
- Imaging Therapeutics, Inc. — 1 clearance
- Osteoimplant Technology, Inc. — 1 clearance
- Sulzer Orthopedics, Inc. — 1 clearance

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

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