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implantcast GmbH

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
—
Website
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LinkedIn
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Facebook
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Email
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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 (1876)

Page 17 of 38
DeviceModel / ReferenceRegistriesClassStatus
Acs® 42003804
FDA UDI
Class IIActive
AGILON® XO PE-glenoid cemented 38030132
FDA UDI
Class IIActive
PB Uni tibial trial insert 40120408
FDA UDI
Class IIActive
PB Uni tibial trial insert 40120310
FDA UDI
Class IIActive
Acs® 4201720400
FDA UDI
Class IIActive
Acs® 42454312
FDA UDI
Class IIActive
EcoFit® hip stem 133° cementless cpTi lateralized 30374112
FDA UDI
Class IIActive
Acs® 42009308
FDA UDI
Class IIActive
Uni FB PE-insert 40100411
FDA UDI
Class IIActive
ACS® Uni femoral resection guide 42160703
FDA UDI
Class IIActive
Acs® 42210514
FDA UDI
Class IIActive
ACS® Uni joint gap feeler 42161757
FDA UDI
Class IActive
Agilon® 78013002
FDA UDI
Class IActive
Acs® 4207510500
FDA UDI
Class IIActive
Acs® 42141612
EUDAMEDFDA UDI
Class IActive
AGILON® trial stem 78512012
FDA UDI
Class IIActive
Acs® 42103105
FDA UDI
Class IActive
Acs® 42081810
FDA UDI
Class IIActive
AGILON® XO trial cap inverse 78633610
FDA UDI
Class IIActive
ACS® Uni joint gap feeler 42161751
FDA UDI
Class IActive
Acs® 42150002
FDA UDI
Class IIActive
AGILON® XO trial cap inverse 78634005
FDA UDI
Class IIActive
Uni FB tibial component LL/RM 40100010
FDA UDI
Class IIActive
AGILON® XO glenosphere neutral 3803404000
FDA UDI
Class IIActive
Acs® 42019213
FDA UDI
Class IActive
AGILON® trial metaphyseal component omarthrosis 78210072
FDA UDI
Class IIActive
Acs® 42140310
FDA UDI
Class IActive
Acs® 42003814
FDA UDI
Class IIActive
Acs® 42451220
FDA UDI
Class IIActive
MUTARS® trial reducer 77300230
FDA UDI
Class IIActive
ic-pin inserter 75120903
FDA UDI
Class IActive
Acs® 42141611
FDA UDI
Class IActive
AGILON® XO cap 38604717
FDA UDI
Class IIActive
implaFit® broach handle easy lock straight 80082020
FDA UDI
Class IActive
AGILON® XO PE-glenoid cemented 38030128
FDA UDI
Class IIActive
Actinia® 80040115
FDA UDI
Class IIActive
Acs® 4207005300
FDA UDI
Class IIActive
EcoFit® NH cup cementless 0220016600
FDA UDI
Class IIActive
Acs® 42181820
EUDAMEDFDA UDI
Class IActive
implaFit® broach 80082007
FDA UDI
Class IActive
implaFit® reamer conical 80083012
FDA UDI
Class IActive
Acs® 42104312
FDA UDI
Class IIActive
trial insert 0° 02253644
FDA UDI
Class IIActive
Acs® 42150066
FDA UDI
Class IActive
Actinia® 80040711
FDA UDI
Class IIActive
AGILON® trial stem 78506011
FDA UDI
Class IIActive
Agilon® 78010225
FDA UDI
Class IIActive
AGILON® metaphyseal component omarthrosis 3821005200
FDA UDI
Class IIActive
PB Uni tibial trial insert 40120112
FDA UDI
Class IIActive
ACS® Uni joint gap feeler 42161760
FDA UDI
Class IActive

Related Companies

Authorised Representatives

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Importers

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Authorities

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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