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Data / Medical devices / Germany / implantcast GmbH

implantcast GmbH: FDA-registered device maker in Buxtehude Lower Saxony, Germany, 20 510(k) clearances

implantcast GmbH is registered with the FDA (registration 3012523063) in Buxtehude Lower Saxony, Germany. It lists 24 device types. The FDA files 20 510(k) clearances under its listings, the newest dated April 24, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch implantcast GmbH
FDA registration number
3012523063
Address
Lueneburger Schanze 26, Buxtehude Lower Saxony, Germany, 21614
Owner or operator
implantcast GmbH (10054139)
Roles
Complaint file establishment, Exporter to the US, Manufacturer
First device listed
October 4, 2017
Registered through
2027
Brand names listed
ACS® LD FB Knee System, ACS® LD Uni FB Knee System, AGILON® XO Shoulder Replacement System, AGILON® XO Shoulder System, Actinia® hip stems, BethaLoc® stem cementless HA, Drilling pin, EPORE® XO cup system and more

Devices it lists

DeviceProduct codeClassRoleSource
AwlHWJ1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
BroachHTQ1Manufactureraccessdata.fda.gov
ExtractorHWB1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Complaint file establishment, Manufactureraccessdata.fda.gov
ImpactorHWA1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Complaint file establishment, Manufactureraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Complaint file establishment, Manufactureraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 24, 2026K252451EPORE® XO cup systemOQISubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
March 30, 2026K260037implantcast Packaging System UpdateLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
March 12, 2026K252401implaFit® short stemsLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
March 10, 2025K241944AGILON® XO Shoulder Replacement SystemKWTSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
October 24, 2024K240391MUTARS® femoral stem cemented 160 mm and 200 mmLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
September 6, 2024K234044ACS® LD FB Knee SystemJWHSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
June 3, 2024K240834EcoFit® short stem cementless cpTiLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
February 16, 2024K231657AGILON® XO Shoulder Replacement SystemKWTSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
October 19, 2023K232371Actinia® hip stemsLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
June 20, 2023K223103BethaLoc® stem cementless HALZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
September 28, 2022K222482AGILON XO Shoulder SystemKWTSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
August 17, 2022K210678implaFit® hip stemsLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
February 3, 2021K203420EcoFit® Hip SystemLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
January 8, 2021K203341ACS LD Uni FB Knee SystemHSXSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
November 12, 2020K191433AGILON® XO Shoulder Replacement SystemHSDSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
October 16, 2020K200045MUTARS Cemented Femoral StemsMEHSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
August 28, 2019K191569Implantcast ic-Bipolar Head SystemKWYSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
March 25, 2019K181778MUTARS Proximal Femur Replacement SystemMEHSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
July 20, 2018K180263EcoFit Vit E Acetabular SystemLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov
September 25, 2017K163577Ecofit® Hip SystemLZOSubstantially EquivalentImplantcast GmbHaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 10, 202188047Class IITerminatedEcoFit 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 cementlA risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factoraccessdata.fda.gov
December 28, 201780498Class IITerminated2M 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 numbPossibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.accessdata.fda.gov

Compare with other makers

Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.