The following data is part of a premarket notification filed by Smith+nephew, Inc with the FDA for Journey Ii Uk™ And Engage™ Cementless Partial Knee System.
| Device ID | K222653 |
| 510k Number | K222653 |
| Device Name: | JOURNEY II UK™ And ENGAGE™ Cementless Partial Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer |
| Applicant | Smith+Nephew, Inc 1450 Brooks Rd Memphis, TN 38116 |
| Contact | Lilian Hren |
| Correspondent | Lilian Hren Smith+Nephew, Inc 1450 Brooks Rd Memphis, TN 38116 |
| Product Code | NJD |
| CFR Regulation Number | 888.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-01 |
| Decision Date | 2022-10-28 |