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US
Last updated May 23, 2026
What implantcast GmbH makes
The company produces reusable trial components for knee arthroplasty, including knee tibia and femur prosthesis trials, as well as tibial inserts and knee arthroplasty wedges. It also manufactures orthopaedic fixation tools such as press-fit femoral stems, broaches, and general internal orthopaedic fixation system implantation kits. Additional products include non-constrained polyethylene acetabular liners and specialized extension pieces, chisels, and extractors for femoral trials.
These devices are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA’s UDI (Unique Device Identification) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does implantcast GmbH manufacture?
implantcast GmbH specializes in reusable orthopaedic devices primarily used in knee arthroplasty procedures. Their product range includes trial components like knee tibia and femur prosthesis trials, tibial inserts, and knee arthroplasty wedges. They also produce orthopaedic fixation tools such as press-fit femoral stems, broaches, and implantation kits for general internal orthopaedic fixation. Additionally, they manufacture non-constrained polyethylene acetabular liners and specialized tools like extension pieces, chisels, and femoral trial extractors.
Where is implantcast GmbH based?
implantcast GmbH is based in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.
Which regulatory registries list implantcast GmbH’s devices?
implantcast GmbH’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements.
How are implantcast GmbH’s devices classified under FDA regulations?
implantcast GmbH’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s purpose, intended use, and potential risks, as outlined in FDA guidelines.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 324369826
Catalogue (1870)
Page 38 of 38| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AGILON® XO Shoulder Replacement System | K191433 | FDA 510(k) | Class II | Active |
| implaFit® hip stems | K210678 | FDA 510(k) | Class II | Active |
| MUTARS® femoral stem cemented 160 mm and 200 mm | K240391 | EUDAMEDFDA 510(k) | Class II | Active |
| EcoFit® Hip System | K203420 | FDA 510(k) | Class II | Active |
| EcoFit Vit E Acetabular System | K180263 | FDA 510(k) | Class II | Active |
| EPORE® XO cup system | K252451 | EUDAMEDFDA 510(k) | Class II | Active |
| AGILON® XO Shoulder Replacement System | K241944 | FDA 510(k) | Class II | Active |
| MUTARS Proximal Femur Replacement System | K181778 | FDA 510(k) | Class II | Active |
| implaFit® short stems | K252401 | FDA 510(k) | Class II | Active |
| AGILON® XO Shoulder Replacement System | K231657 | FDA 510(k) | Class II | Active |
| MUTARS Cemented Femoral Stems | K200045 | FDA 510(k) | Class II | Active |
| implantcast Packaging System Update | K260037 | EUDAMEDFDA 510(k) | Class II | Active |
| Implantcast ic-Bipolar Head System | K191569 | FDA 510(k) | Class II | Active |
| EcoFit® short stem cementless cpTi | K240834 | FDA 510(k) | Class II | Active |
| Actinia® hip stems | K232371 | FDA 510(k) | Class II | Active |
| Ecofit® Hip System | K163577 | FDA 510(k) | Class II | Active |
| ACS® LD FB Knee System | K234044 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| ACS LD Uni FB Knee System | K203341 | FDA 510(k) | Class II | Active |
| BethaLoc® stem cementless HA | K223103 | FDA 510(k) | Class II | Active |
| AGILON XO Shoulder System | K222482 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- implantcast GmbH Buxtehude Lower Saxony · DE FEI 3012523063