ClearanceBrief
Company · DE

Implantcast GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (3 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented12
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer1
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 24, 2026K252451EPORE® XO cup system
Implantcast GmbH, DE
OQI
Mar 30, 2026K260037implantcast Packaging System Update
Implantcast GmbH, DE
LZO
Mar 12, 2026K252401implaFit® short stems
Implantcast GmbH, DE
LZO
Mar 10, 2025K241944AGILON® XO Shoulder Replacement System
Implantcast GmbH, DE
KWT
Oct 24, 2024K240391MUTARS® femoral stem cemented 160 mm and 200 mm
Implantcast GmbH, DE
LZO
Sep 6, 2024K234044ACS® LD FB Knee System
Implantcast GmbH, DE
JWH
Jun 3, 2024K240834EcoFit® short stem cementless cpTi
Implantcast GmbH, DE
LZO
Feb 16, 2024K231657AGILON® XO Shoulder Replacement System
Implantcast GmbH, DE
KWT
Oct 19, 2023K232371Actinia® hip stems
Implantcast GmbH, DE
LZO
Jun 20, 2023K223103BethaLoc® stem cementless HA
Implantcast GmbH, DE
LZO
Sep 28, 2022K222482AGILON XO Shoulder System
Implantcast GmbH, DE
KWT
Aug 17, 2022K210678implaFit® hip stems
Implantcast GmbH, DE
LZO
Feb 3, 2021K203420EcoFit® Hip System
Implantcast GmbH, DE
LZO
Jan 8, 2021K203341ACS LD Uni FB Knee System
Implantcast GmbH, DE
HSX
Nov 12, 2020K191433AGILON® XO Shoulder Replacement System
Implantcast GmbH, DE
HSD
Oct 16, 2020K200045MUTARS Cemented Femoral Stems
Implantcast GmbH, DE
MEH
Aug 28, 2019K191569Implantcast ic-Bipolar Head System
Implantcast GmbH, DE
KWY
Mar 25, 2019K181778MUTARS Proximal Femur Replacement System
Implantcast GmbH, DE
MEH
Jul 20, 2018K180263EcoFit Vit E Acetabular System
Implantcast GmbH, DE
LZO
Sep 25, 2017K163577Ecofit® Hip System
Implantcast GmbH, DE
LZO

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 9, 2021IMPLANTCAST GMBH
EcoFit 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; 02200
Terminated		 LZOK163577
Dec 28, 2017IMPLANTCAST GMBH
2M 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 0242444
Terminated		 LZONone listed
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