K222653 is an FDA 510(k) clearance for the JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System. This device is classified as a Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (Class II - Special Controls, product code NJD).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 28, 2022, 57 days after receiving the submission on September 1, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3535. Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery..
| 510(k) Number | K222653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2022 |
| Decision Date | October 28, 2022 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3535 |
| Definition | Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery. |