PATELLAR COMPONENT FOR LUBINUS PATELLAR
Device Facts
| Record ID | K800800 |
|---|---|
| Device Name | PATELLAR COMPONENT FOR LUBINUS PATELLAR |
| Applicant | Waldemar Link GmbH & Co. KG |
| Product Code | HTG · Orthopedic |
| Decision Date | Apr 21, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3580 |
| Device Class | Class 2 |
Regulatory Classification
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).
