implantcast GmbH
Buxtehude Lower Saxony, DE
implantcast GmbH appears in FDA device records in Buxtehude Lower Saxony, DE. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for implantcast GmbH between 2017 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252451 | EPORE® XO cup system | OQI | Substantially Equivalent | |
| K260037 | implantcast Packaging System Update | LZO | Substantially Equivalent | |
| K252401 | implaFit® short stems | LZO | Substantially Equivalent | |
| K241944 | AGILON® XO Shoulder Replacement System | KWT | Substantially Equivalent | |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | LZO | Substantially Equivalent | |
| K234044 | ACS® LD FB Knee System | JWH | Substantially Equivalent | |
| K240834 | EcoFit® short stem cementless cpTi | LZO | Substantially Equivalent | |
| K231657 | AGILON® XO Shoulder Replacement System | KWT | Substantially Equivalent | |
| K232371 | Actinia® hip stems | LZO | Substantially Equivalent | |
| K223103 | BethaLoc® stem cementless HA | LZO | Substantially Equivalent | |
| K222482 | AGILON XO Shoulder System | KWT | Substantially Equivalent | |
| K210678 | implaFit® hip stems | LZO | Substantially Equivalent | |
| K203420 | EcoFit® Hip System | LZO | Substantially Equivalent | |
| K203341 | ACS LD Uni FB Knee System | HSX | Substantially Equivalent | |
| K191433 | AGILON® XO Shoulder Replacement System | HSD | Substantially Equivalent | |
| K200045 | MUTARS Cemented Femoral Stems | MEH | Substantially Equivalent | |
| K191569 | Implantcast ic-Bipolar Head System | KWY | Substantially Equivalent | |
| K181778 | MUTARS Proximal Femur Replacement System | MEH | Substantially Equivalent | |
| K180263 | EcoFit Vit E Acetabular System | LZO | Substantially Equivalent | |
| K163577 | Ecofit® Hip System | LZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012523063 | 3012523063 | implantcast GmbH | Lueneburger Schanze 26, Buxtehude Lower Saxony 21614 DE | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HTWBit, Drill
- HTQBroach
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- FZYHammer, Surgical
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- HWAImpactor
- LXHOrthopedic Manual Surgical Instrument
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- HTOReamer
- HXXScrewdriver
- PHXShoulder Prosthesis, Reverse Configuration
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2050-2021 | 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; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover; | A 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 factor. | Class II | Terminated | |
| Z-2517-2018 | 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 02424448 Size 46/52 mm REF number 02424652 | Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain