| K-number | K250677 |
| Device name | LEGION Total Knee System |
| Applicant | Smith & Nephew, Inc. |
| Product code | JWH |
| Device class | Class II |
| Decision date | Apr 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3560 |
The LEGION Medial Stabilized Insert with JOURNEY Lock is a tibial insert (knee prosthesis component) for total knee replacement in patients with rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative joint disease. It is a polymer insert intended for use in skeletally mature patients undergoing primary or revision surgery and is provided sterile for single use only.
The device maintains the same JOURNEY locking mechanism, material composition (XLPE), manufacturing processes, and packaging as the predicate devices. The primary design modification is a new articulating surface featuring a flatter lateral plateau and extended medial geometry to match the asymmetry of the tibial baseplate, similar to the JOURNEY II Medial Dished articulating surface.
Tibiofemoral Constraint Testing per ASTM F1223-20 and ISO 21536; Tibiofemoral Contact Area Testing per ISO 21536.
The device is substantially equivalent because it has identical overall function, intended use, material composition, manufacturing processes, and packaging to the predicate LEGION CR High Flex Insert (K200407), with only the articulating surface geometry modified. The new articulating surface design is comparable to an existing legally marketed predicate (JOURNEY II Medial Dished, K211671), and bench testing demonstrated acceptable constraint and contact area outcomes consistent with the predicates.
View the full FDA submission: accessdata.fda.gov