HTG · Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
Orthopedic · 21 CFR 888.3580 · Class 2
Overview
| Product Code | HTG |
|---|---|
| Device Name | Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented |
| Regulation | 21 CFR 888.3580 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum, intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a retropatellar resurfacing component and an orthopedic screw to transfix the patellar remnant. This generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).
Classification Rationale
(1) Class II when intended for treatment of degenerative and posttraumatic patellar arthritis.(2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K800800 | PATELLAR COMPONENT FOR LUBINUS PATELLAR | Waldemar Link GmbH & Co. KG | Apr 21, 1980 | SESE |
| K771708 | WORRELL PATELLA | Depuy, Inc. | Oct 6, 1977 | SESE |
Top Applicants
- Waldemar Link GmbH & Co. KG — 1 clearance
- Depuy, Inc. — 1 clearance
