Draper, UT, US · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 2 | 2025-05-22 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2024-10-25 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 1 | 2025-12-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2024-10-11 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 1 | 2021-12-21 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 1 | 2021-12-16 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2021-07-14 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | 1 | 2020-03-31 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-19 | K253161 | Balanced Knee System TriMax Porous Femoral Components | MBH | Class II | Orthopedic |
| 2025-05-22 | K251052 | Trivicta® Hip Stem | MEH | Class II | Orthopedic |
| 2024-10-25 | K242984 | BKS Revision System | JWH | Class II | Orthopedic |
| 2024-10-11 | K242833 | Legend® Acetabular Shell | LPH | Class II | Orthopedic |
| 2024-03-08 | K233758 | Trivicta Hip Stem | MEH | Class II | Orthopedic |
| 2023-10-25 | K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | JWH | Class II | Orthopedic |
| 2021-12-21 | K211086 | The Progen Trochanteric Nail System | HSB | Class II | Orthopedic |
| 2021-12-16 | K211471 | Balanced Knee System Uni | HSX | Class II | Orthopedic |
| 2021-07-14 | K203023 | Pisces Spinal System | NKB | Class II | Orthopedic |
| 2020-03-31 | K200281 | The Gecko Spinal System | OWI | Class II | Orthopedic |