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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 33 of 38| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PB Uni tibial trial component | 40120021 | FDA UDI | Class II | Active |
| Acs® | 42454517 | FDA UDI | Class II | Active |
| Acs® | 42155510 | FDA UDI | Class I | Active |
| BethaLoc® | 87001175 | FDA UDI | Class I | Active |
| Acs® | 42081210 | FDA UDI | Class II | Active |
| implacross® E PE insert 10º | 02343644 | FDA UDI | Class II | Active |
| AGILON® XO trial cap inverse | 78633205 | FDA UDI | Class II | Active |
| ic-head Biolox®delta taper 12/14 | 25863200 | FDA UDI | Class II | Active |
| Acs® | 42182015 | FDA UDI | Class I | Active |
| Acs® | 42451415 | FDA UDI | Class II | Active |
| PE – cup insert 0° | 02803444 | FDA UDI | Class II | Active |
| Acs® | 42142213 | FDA UDI | Class I | Active |
| MUTARS® screw for connecting part | 57300106 | FDA UDI | Class II | Active |
| Uni FB PE-insert | 40100412 | FDA UDI | Class II | Active |
| Agilon® | 38210083 | FDA UDI | Class II | Active |
| Acs® | 42455412 | FDA UDI | Class II | Active |
| implaFit® broach | 80082010 | FDA UDI | Class I | Active |
| Acs® | 42150001 | FDA UDI | Class II | Active |
| Acs® | 42140210 | FDA UDI | Class I | Active |
| AGILON® stem cementless | 38506018 | FDA UDI | Class II | Active |
| Acs® | 42150064 | FDA UDI | Class I | Active |
| Acs® | 42019204 | FDA UDI | Class I | Active |
| Acs® | 42454513 | FDA UDI | Class II | Active |
| AGILON® trial cap | 78004117 | FDA UDI | Class II | Active |
| Acs® | 42150464 | FDA UDI | Class II | Active |
| EcoFit® cup cementless incl. central hole cover | 02200056 | FDA UDI | Class II | Active |
| EcoFit® | 30421875 | FDA UDI | Class II | Active |
| Tibial cutting block | 42160371 | FDA UDI | Class II | Active |
| Acs® | 42150058 | FDA UDI | Class I | Active |
| BethaLoc® | 87001007 | FDA UDI | Class II | Active |
| Acs® | 4207005500 | FDA UDI | Class II | Active |
| AGILON® trial screw | 78210037 | FDA UDI | Class II | Active |
| PB Uni tibial trial insert | 40120410 | FDA UDI | Class II | Active |
| Agilon® | 78210083 | FDA UDI | Class I | Active |
| Acs® | 42150205 | FDA UDI | Class I | Active |
| Actinia® | 80040010 | FDA UDI | Class II | Active |
| Acs® | 42102202 | FDA UDI | Class II | Active |
| Acs® | 42454613 | FDA UDI | Class II | Active |
| AGILON® XO inverse cap base | 38633605 | FDA UDI | Class II | Active |
| AGILON® XO glenosphere neutral incl. screw | 38034032 | FDA UDI | Class II | Active |
| Acs® | 42181220 | FDA UDI | Class I | Active |
| Acs® | 42454515 | FDA UDI | Class II | Active |
| AGILON® counter sleeve M6 | 78010125 | FDA UDI | Class I | Active |
| Acs® | 42204055 | FDA UDI | Class II | Active |
| EcoFit® cup cementless | 0220004800 | FDA UDI | Class II | Active |
| ACS® Uni trial femoral component | 42160352 | FDA UDI | Class II | Active |
| AGILON® humeral cutting block | 78010140 | FDA UDI | Class I | Active |
| AGILON® XO inverse cap base | 38634005 | FDA UDI | Class II | Active |
| Acs® | 42150454 | FDA UDI | Class II | Active |
| implaFit® trial neck K12/14 lat. stem | 80084067 | FDA UDI | 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