Mutars Femoral Stem Cemented 160 mm and 200 mm
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MUTARS® EUDAMED
- Device Name
- - EUDAMED
- Model / Reference
- MUE12HTAMTSINST EUDAMED77471415 EUDAMEDMUTHUSTAMUNCCL EUDAMED52471515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048844700355 EUDAMED04048844518080 EUDAMED
- Basic UDI-DI
- 4048844MUE12HTAMTSINSTBK EUDAMED4048844MUTHUSTAMUNCCLE7 EUDAMED
- Direct Marketing DI
- 04048844700355 EUDAMED
- 510(k) Number
- K240391 FDA 510(k)
- FDA Product Code
- LZO FDA 510(k)
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDP0901040202 SHOULDER PROSTHESES MODULAR STEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass III 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 EUDAMEDCzechia EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Mutars Femoral Stem Cemented 160 mm and 200 mm is a cemented orthopedic femoral stem, designed for use in total hip arthroplasty procedures. It is intended to provide structural support and stability within the proximal femur, facilitating load-bearing and joint function after implantation.
This device is supplied sterile and intended for single-use, adhering to FDA 510K and MDR regulatory standards. Available in two lengths (160 mm and 200 mm), it is manufactured by implantcast GmbH and distributed with appropriate packaging for surgical use. Compliance with orthopedic product codes (LZO) ensures it meets established safety and performance criteria for cemented femoral components.
Frequently asked questions
What are the key differences between the 160 mm and 200 mm versions of the MUTARS® femoral stem, and how might a surgeon choose between them?
The MUTARS® femoral stem is available in two lengths: 160 mm and 200 mm. The choice depends on the patient’s anatomy and bone structure. The 160 mm version is designed for shorter femurs or cases where a shorter stem is clinically appropriate, while the 200 mm version accommodates longer bone lengths or patients requiring additional proximal support. Surgeons select the length based on preoperative imaging and the need for optimal fit, stability, and load distribution during total hip arthroplasty.
Is the MUTARS® femoral stem reusable, or is it intended for single-use only, and why does this matter?
The MUTARS® femoral stem is explicitly intended for single-use only, as stated in the device description. This ensures sterility and reduces the risk of cross-contamination or degradation from reprocessing. Single-use also aligns with modern surgical best practices for orthopedic implants, where sterility and traceability are critical for patient safety and regulatory compliance.
How is the MUTARS® femoral stem packaged and prepared for surgical use, and what should be checked before opening?
The device is supplied sterile in packaging designed for surgical use, as noted in the description. Before opening, verify the sterility indicators (e.g., peel pouches or sterile barriers) are intact and uncompromised. Check the expiration date on the packaging and ensure the correct length (160 mm or 200 mm) matches the surgical plan. Always follow manufacturer guidelines for handling to maintain sterility.
What regulatory pathways does the MUTARS® femoral stem follow, and how does this affect its use in clinical practice?
The device follows FDA 510K and MDR (Medical Device Regulation) pathways, as listed under authorizations. The FDA clearance is via a Traditional 510(k) process, determined as *Substantially Equivalent* (SESE) by the Orthopedic (OR) Advisory Committee. Clinically, this means the device has undergone rigorous review for safety and performance, ensuring it meets established standards for cemented femoral stems in total hip arthroplasty. Compliance with product code LZO further confirms adherence to orthopedic implant criteria.
Are there any specific storage requirements for the MUTARS® femoral stem before surgery, and why are they important?
While the device data does not specify exact storage conditions, sterile medical devices like this typically require protection from moisture, extreme temperatures, and physical damage. Store the packaging in a clean, dry environment away from direct sunlight or sources of contamination. Proper storage preserves sterility and integrity until use, preventing potential compromise of the implant’s performance or safety during surgery.
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.
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 | K240391 | Class II | Active |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (3)
- FDA 510(k) K240391 24 fields · synced Sep 30, 2026
- EUDAMED 177aa03a-af0c-4db6-8148-fe64e9b88104 61 fields · synced Aug 1, 2026
- EUDAMED 4431388e-0907-465c-b661-dab58134c489 61 fields · synced Sep 30, 2026