DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
Device Facts
| Record ID | K122395 |
|---|---|
| Device Name | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS |
| Applicant | DePuy Orthopaedics, Inc. |
| Product Code | HSN · Orthopedic |
| Decision Date | Oct 31, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3110 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
