Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Implantcast GmbH with 20 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Apr 24, 2026: EPORE® XO cup system.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 24, 2026 | EPORE® XO cup systemK252451 · OQI | 510(k) clearances |
| Mar 30, 2026 | implantcast Packaging System UpdateK260037 · LZO | 510(k) clearances |
| Mar 12, 2026 | implaFit® short stemsK252401 · LZO | 510(k) clearances |
| Mar 10, 2025 | AGILON® XO Shoulder Replacement SystemK241944 · KWT | 510(k) clearances |
| Oct 24, 2024 | MUTARS® femoral stem cemented 160 mm and 200 mmK240391 · LZO | 510(k) clearances |
| Sep 6, 2024 | ACS® LD FB Knee SystemK234044 · JWH | 510(k) clearances |
| Jun 3, 2024 | EcoFit® short stem cementless cpTiK240834 · LZO | 510(k) clearances |
| Feb 16, 2024 | AGILON® XO Shoulder Replacement SystemK231657 · KWT | 510(k) clearances |
| May 10, 2021 | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoClass II · A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could le | Device recalls |
| Dec 28, 2017 | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size Class II · Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
