IMPLANTCAST GMBH
FDA Regulatory Profile
IMPLANTCAST GMBH appears in FDA public data with 2 recalls, 20 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2050-2021, Class II) was initiated on May 10, 2021. Its most recent 510(k) clearance was granted on April 24, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2050-2021 | Class II | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia | May 10, 2021 |
| Z-2517-2018 | Class II | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. S | December 28, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252451 | EPORE® XO cup system | April 24, 2026 |
| K260037 | implantcast Packaging System Update | March 30, 2026 |
| K252401 | implaFit® short stems | March 12, 2026 |
| K241944 | AGILON® XO Shoulder Replacement System | March 10, 2025 |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | October 24, 2024 |
| K234044 | ACS® LD FB Knee System | September 6, 2024 |
| K240834 | EcoFit® short stem cementless cpTi | June 3, 2024 |
| K231657 | AGILON® XO Shoulder Replacement System | February 16, 2024 |
| K232371 | Actinia® hip stems | October 19, 2023 |
| K223103 | BethaLoc® stem cementless HA | June 20, 2023 |
| K222482 | AGILON XO Shoulder System | September 28, 2022 |
| K210678 | implaFit® hip stems | August 17, 2022 |
| K203420 | EcoFit® Hip System | February 3, 2021 |
| K203341 | ACS LD Uni FB Knee System | January 8, 2021 |
| K191433 | AGILON® XO Shoulder Replacement System | November 12, 2020 |
| K200045 | MUTARS Cemented Femoral Stems | October 16, 2020 |
| K191569 | Implantcast ic-Bipolar Head System | August 28, 2019 |
| K181778 | MUTARS Proximal Femur Replacement System | March 25, 2019 |
| K180263 | EcoFit Vit E Acetabular System | July 20, 2018 |
| K163577 | Ecofit® Hip System | September 25, 2017 |