Implantcast Packaging System Update
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- - EUDAMED
- Model / Reference
- MUE15FSHSINST EUDAMED77470001 EUDAMEDUEC12TI0INST EUDAMED02252844 EUDAMEDUEC12THINST EUDAMED79654000 EUDAMEDKNB07FCBINST EUDAMED42200836 EUDAMEDUMUT05RD1INST EUDAMED42203124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048844699840 EUDAMED04048844109127 EUDAMED04048844352301 EUDAMED04048844041175 EUDAMED04048844318284 EUDAMED
- Basic UDI-DI
- 4048844MUE15FSHSINST6V EUDAMED4048844UEC12TI0INSTPV EUDAMED4048844UEC12THINST5Y EUDAMED4048844KNB07FCBINSTJC EUDAMED4048844UMUT05RD1INSTTL EUDAMED
- Direct Marketing DI
- 04048844699840 EUDAMED04048844109127 EUDAMED04048844352301 EUDAMED04048844041175 EUDAMED
- 510(k) Number
- K260037 FDA 510(k)
- FDA Product Code
- LZO FDA 510(k)
- EMDN Code
- L0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE EUDAMEDL091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDL0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMEDL091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Market of Registration
- Germany EUDAMEDItaly EUDAMEDTürkiye EUDAMEDNetherlands EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Implantcast Packaging System Update is a semi-constrained hip prosthesis packaging solution designed for orthopedic applications. It is intended to ensure the integrity, sterility, and traceability of hip implants during storage and transport, adhering to regulatory standards for medical device packaging.
This system is supplied as a sterile, single-use packaging solution for hip implants, complying with FDA 510(k) clearance (K260037) and MDR authorisation. It is intended for use in orthopedic settings, where proper packaging is critical to maintaining device sterility and preventing contamination. The system is classified under product code LZO and is manufactured by Implantcast GmbH, based in Buxtehude, Germany.
Frequently asked questions
What is the primary purpose of the Implantcast Packaging System Update in orthopedic procedures?
The Implantcast Packaging System Update is designed specifically to maintain the integrity, sterility, and traceability of hip implants during storage and transport. This ensures that the implants remain uncontaminated and ready for use in orthopedic surgeries, where maintaining sterility is critical to patient safety and procedural success.
Is this packaging system reusable, or is it intended for single-use only?
The Implantcast Packaging System Update is explicitly labeled as a single-use solution. This design choice aligns with best practices for medical device packaging to prevent cross-contamination between uses and ensure compliance with regulatory sterility standards.
How does the system ensure compliance with regulatory standards for medical device packaging?
The system is FDA 510(k)-cleared (K260037) and MDR-authorized, meaning it meets stringent requirements for sterility, traceability, and packaging integrity. It is classified under product code LZO, which is specific to orthopedic devices, ensuring it adheres to both U.S. and EU regulatory frameworks for medical device packaging.
What types of hip implants is this packaging system intended to protect?
While the system is designed for semi-constrained hip prostheses, the exact implant models or sizes it accommodates are not specified in the provided data. However, its purpose is to ensure sterility and protection for hip implants used in orthopedic surgeries, where packaging integrity is paramount.
How should the packaging system be stored to maintain its sterility and functionality?
The system is sterile upon delivery, but specific storage instructions (e.g., temperature, humidity, or light exposure) are not detailed in the provided data. Generally, medical packaging should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and structural integrity until use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: implantcast – Ihr innovativer Partner für Implantate, implantcast.de, implantcast Packaging System Update 510(k) K260037 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K260037 | Class II | Active |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (6)
- FDA 510(k) K260037 24 fields · synced Sep 30, 2026
- EUDAMED f97e1021-1ef4-4865-86a7-5107699f3ff0 61 fields · synced Jul 8, 2026
- EUDAMED d3d985f0-df34-475d-bee6-8c6fc1ff9057 61 fields · synced Aug 1, 2026
- EUDAMED c6d968cd-4e41-4266-9f42-d93a582f3b5c 61 fields · synced Aug 1, 2026
- EUDAMED 6390244e-4f97-434f-9f9c-4d8661295079 61 fields · synced Sep 17, 2026
- EUDAMED c2724cb3-8d3e-40e9-b8ef-584c4a908e3f 61 fields · synced Sep 17, 2026