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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 (1870)

Page 30 of 38
DeviceModel / ReferenceRegistriesClassStatus
EcoFit® hip stem coxa vara cementless cpTi standard 30388175
FDA UDI
Class IIActive
Acs® 42453212
FDA UDI
Class IIActive
EcoFit® broach for short stem 133° 70404100
FDA UDI
Class IActive
Acs® 42150468
FDA UDI
Class IIActive
Acs® 4207010800
FDA UDI
Class IIActive
MUTARS® screw 57921004
FDA UDI
Class IIActive
AGILON® XO cap 38605014
FDA UDI
Class IIActive
guide wire 00510918
FDA UDI
Class IActive
Acs® 42006104
FDA UDI
Class IIActive
cancellous screw angle stable 57944228
FDA UDI
Class IIActive
PB Uni tibial trial insert 40120308
FDA UDI
Class IIActive
Acs® 42103103
FDA UDI
Class IActive
Acs® 42155512
FDA UDI
Class IActive
Acs® 42004235
FDA UDI
Class IIActive
EcoFit® short stem lateralized cementless cpTi 30421500
FDA UDI
Class IIActive
spongiosa screw flat head 02801050
FDA UDI
Class IIActive
Acs® 42150506
FDA UDI
Class IActive
Acs® 42452320
FDA UDI
Class IIActive
MUTARS® rasp for femoral stem 77600116
FDA UDI
Class IIActive
Acs® 42142312
FDA UDI
Class IActive
MUTARS® extension piece 57722506
FDA UDI
Class IIActive
Acs® 42220004
FDA UDI
Class IIActive
AGILON® XO cap 38604117
FDA UDI
Class IIActive
BethaLoc® 87001180
FDA UDI
Class IActive
implaFit® hip stem with collar cemented standard 80080007
FDA UDI
Class IIActive
Actinia® 80049011
FDA UDI
Class IIActive
implaFit® hip stem cementless lateralized 80020010
FDA UDI
Class IIActive
resection guide 80083000
FDA UDI
Class IActive
BethaLoc® 87001011
FDA UDI
Class IIActive
starter awl tapered 75120019
FDA UDI
Class IActive
implacross® E PE insert 10° 4mm offset 02363248
FDA UDI
Class IIActive
Acs® 42130332
FDA UDI
Class IActive
head of femur pattern 50-55mm in 1mm steps 79607003
FDA UDI
Class IActive
EcoFit® short stem standard cementless cpTi 30320100
FDA UDI
Class IIActive
Acs® 42155413
FDA UDI
Class IActive
Acs® 42452215
FDA UDI
Class IIActive
AGILON® stem cementless 38524016
FDA UDI
Class IIActive
implacross® E PE insert 0º 02333239
FDA UDI
Class IIActive
Acs® 42150206
FDA UDI
Class IActive
AGILON® metaphyseal component omarthrosis 3821006300
FDA UDI
Class IIActive
Acs® 42142210
FDA UDI
Class IActive
EcoFit® cup cementless 0220006400
FDA UDI
Class IIActive
implacross® E PE insert 10º 02343244
FDA UDI
Class IIActive
MUTARS® rasp for femoral stem 77600117
FDA UDI
Class IIActive
EcoFit® NH cup cementless incl. central hole cover 02200150
FDA UDI
Class IIActive
Agilon® 78010240
FDA UDI
Class IIActive
trial insert 10° 4mm offset 02463248
FDA UDI
Class IIActive
EcoFit® broach 133° 70403150
FDA UDI
Class IActive
AGILON® metaphyseal component omarthrosis incl. safety screw 38210073
FDA UDI
Class IIActive
PB Uni tibial trial component 40120013
FDA UDI
Class IIActive

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