Buxtehude, DE · 16 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 8 | 2026-03-30 |
| KWT | — | — | — | 3 | 2025-03-10 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | 1 | 2026-04-24 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 1 | 2024-09-06 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 1 | 2021-01-08 |
| HSD | — | — | — | 1 | 2020-11-12 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 1 | 2020-10-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-05-10 | Class II | Terminated | Z-2050-2021 | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole … | — | A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or re… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-24 | K252451 | EPORE® XO cup system | OQI | Class II | Orthopedic |
| 2026-03-30 | K260037 | implantcast Packaging System Update | LZO | Class II | Orthopedic |
| 2026-03-12 | K252401 | implaFit® short stems | LZO | Class II | Orthopedic |
| 2025-03-10 | K241944 | AGILON® XO Shoulder Replacement System | KWT | — | — |
| 2024-10-24 | K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | LZO | Class II | Orthopedic |
| 2024-09-06 | K234044 | ACS® LD FB Knee System | JWH | Class II | Orthopedic |
| 2024-06-03 | K240834 | EcoFit® short stem cementless cpTi | LZO | Class II | Orthopedic |
| 2024-02-16 | K231657 | AGILON® XO Shoulder Replacement System | KWT | — | — |
| 2023-10-19 | K232371 | Actinia® hip stems | LZO | Class II | Orthopedic |
| 2023-06-20 | K223103 | BethaLoc® stem cementless HA | LZO | Class II | Orthopedic |
| 2022-09-28 | K222482 | AGILON XO Shoulder System | KWT | — | — |
| 2022-08-17 | K210678 | implaFit® hip stems | LZO | Class II | Orthopedic |
| 2021-02-03 | K203420 | EcoFit® Hip System | LZO | Class II | Orthopedic |
| 2021-01-08 | K203341 | ACS LD Uni FB Knee System | HSX | Class II | Orthopedic |
| 2020-11-12 | K191433 | AGILON® XO Shoulder Replacement System | HSD | — | — |
| 2020-10-16 | K200045 | MUTARS Cemented Femoral Stems | MEH | Class II | Orthopedic |