HSH · Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Orthopedic · 21 CFR 888.3590 · Class 2
Overview
| Product Code | HSH |
|---|---|
| Device Name | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) |
| Regulation | 21 CFR 888.3590 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073233 | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Advanced Bio-Surfaces, Inc. | Jan 28, 2008 | SESE |
| K053094 | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 | Advanced Bio-Surfaces, Inc. | Feb 6, 2006 | SESE |
| K033242 | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Imaging Therapeutics, Inc. | Dec 31, 2003 | SESE |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | Osteoimplant Technology, Inc. | Nov 20, 2002 | SESE |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | Sulzer Orthopedics, Inc. | Jan 4, 2001 | SESE |
Top Applicants
- Advanced Bio-Surfaces, Inc. — 2 clearances
- Sulzer Orthopedics, Inc. — 1 clearance
- Osteoimplant Technology, Inc. — 1 clearance
- Imaging Therapeutics, Inc. — 1 clearance
