Grand Rapids, MI, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 4 | 2026-04-13 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | 2 | 2026-09-08 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | 1 | 2022-03-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-08 | K262173 | N22 Offset Humeral Head | KWT | Class II | Orthopedic |
| 2026-04-13 | K254128 | InSet Reverse Total Shoulder System | PHX | Class II | Orthopedic |
| 2026-01-15 | K252516 | N22 EZ Glenosphere | PHX | Class II | Orthopedic |
| 2025-09-26 | K252221 | Inset Reverse Total Shoulder System | PHX | Class II | Orthopedic |
| 2025-02-11 | K241817 | InSet Total Shoulder System | KWT | Class II | Orthopedic |
| 2022-03-11 | K213615 | Shoulder Innovations Total Shoulder System | PKC | Class II | Orthopedic |
| 2021-08-20 | K210533 | Inset Reverse Total Shoulder System | PHX | Class II | Orthopedic |