Implantcast GmbH
Implantcast GmbH holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Implantcast GmbH
FDA recalls by Implantcast GmbH
- Z-2050-2021 — EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;
- Z-2517-2018 — 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Implantcast GmbH
- K252451 — EPORE® XO cup system
- K260037 — implantcast Packaging System Update
- K252401 — implaFit® short stems
- K241944 — AGILON® XO Shoulder Replacement System
- K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm
- K234044 — ACS® LD FB Knee System
- K240834 — EcoFit® short stem cementless cpTi
- K231657 — AGILON® XO Shoulder Replacement System
- K232371 — Actinia® hip stems
- K223103 — BethaLoc® stem cementless HA
- K222482 — AGILON XO Shoulder System
- K210678 — implaFit® hip stems
- K203420 — EcoFit® Hip System
- K203341 — ACS LD Uni FB Knee System
- K191433 — AGILON® XO Shoulder Replacement System
- K200045 — MUTARS Cemented Femoral Stems
- K191569 — Implantcast ic-Bipolar Head System
- K181778 — MUTARS Proximal Femur Replacement System
- K180263 — EcoFit Vit E Acetabular System
- K163577 — Ecofit® Hip System
Data sourced from openFDA. This site is unofficial and independent of the FDA.