Implantcast GmbH
Medical device manufacturer in Buxtehude, DE.
20510(k) clearances
0PMA approvals
2recalls
Device types
- LZO Prosthesis, Hip, Semi-Constrained… 10
- KWT Prosthesis, Shoulder, Non-Constrained… 3
- MEH Prosthesis, Hip, Semi-Constrained… 2
- KWY Prosthesis, Hip, Hemi-, Femoral… 1
- HSD Prosthesis, Shoulder, Hemi-, Humeral… 1
- HSX Prosthesis, Knee, Femorotibial… 1
- JWH Prosthesis, Knee, Patellofemorotibial… 1
- OQI Hip, Semi-Constrained, Cemented… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252451 | EPORE® XO cup systemOQI · Traditional | 04/24/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | 03/12/2026SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | 03/10/2025SE |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mmLZO · Traditional | 10/24/2024SE |
| K234044 | ACS® LD FB Knee SystemJWH · Traditional | 09/06/2024SE |
| K240834 | EcoFit® short stem cementless cpTiLZO · Traditional | 06/03/2024SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | 02/16/2024SE |
| K232371 | Actinia® hip stemsLZO · Traditional | 10/19/2023SE |
| K223103 | BethaLoc® stem cementless HALZO · Traditional | 06/20/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | 09/28/2022SE |
| K210678 | implaFit® hip stemsLZO · Traditional | 08/17/2022SE |
| K203420 | EcoFit® Hip SystemLZO · Traditional | 02/03/2021SE |
| K203341 | ACS LD Uni FB Knee SystemHSX · Traditional | 01/08/2021SE |
| K191433 | AGILON® XO Shoulder Replacement SystemHSD · Traditional | 11/12/2020SE |
| K200045 | MUTARS Cemented Femoral StemsMEH · Traditional | 10/16/2020SE |
| K191569 | Implantcast ic-Bipolar Head SystemKWY · Traditional | 08/28/2019SE |
| K181778 | MUTARS Proximal Femur Replacement SystemMEH · Traditional | 03/25/2019SE |
| K180263 | EcoFit Vit E Acetabular SystemLZO · Traditional | 07/20/2018SE |
| K163577 | Ecofit® Hip SystemLZO · Traditional | 09/25/2017SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2050-2021 Class II | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup…A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup… | 05/10/2021Terminated |
| Z-2517-2018 Class II | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular…Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly… | 12/28/2017Terminated |