ACS LD FB Knee System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ACS® FB EUDAMEDACS® FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- - EUDAMEDFB trial PE insert PS FDA UDIFB tibial trial plate 3.5R FDA UDI
- Model / Reference
- 42141613 EUDAMEDFDA UDI42150439 EUDAMEDFDA UDIKNB12FBTTPINST EUDAMEDKNB12FBTPEIPINST EUDAMED
- Description
- FB trial PE insert PS FDA UDIFB tibial trial plate 3.5R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844336462 EUDAMEDFDA UDI04048844118358 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048844KNB12FBTTPINSTK5 EUDAMED4048844KNB12FBTPEIPINSTRK EUDAMED
- Direct Marketing DI
- 04048844118358 EUDAMED04048844336462 EUDAMED
- 510(k) Number
- K234044 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Knee tibia prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)Class I FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)888.4800 FDA UDI
- Market of Registration
- Türkiye EUDAMEDGermany EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The ACS LD FB Knee System is a total knee arthroplasty device designed to replace damaged knee joint articulations in skeletally mature patients. It features a fixed-bearing polyethylene (PE) insert secured to the tibial component via a snap mechanism, offering varying congruency options (standard, hyperflex, ultra) to accommodate different mobility requirements. The system is intended for use in patients with unicompartmental osteoarthritis and intact cruciate and collateral ligaments, providing pain relief and improved mobility through joint articulation replacement.
This device is supplied as a modular system for surgical use in orthopedic settings, with components including femoral, tibial, and polyethylene inserts. It is intended for single-use and requires sterile handling per standard orthopedic protocols. The system adheres to FDA 510(k) clearance (K234044) and MDR compliance, with no MRI safety restrictions specified. Storage and handling follow manufacturer guidelines for implantable orthopedic devices.
Frequently asked questions
What types of knee mobility needs does the ACS® LD FB Knee System accommodate, and how does it achieve this?
The ACS® LD FB Knee System is designed to address varying knee mobility requirements through its fixed-bearing polyethylene insert, which snaps onto the tibial component. It offers three congruency options—standard, hyperflex, and ultra—to better match patients' flexibility needs, particularly for those with unicompartmental osteoarthritis and intact ligaments. This modular design allows surgeons to select the appropriate insert based on the patient’s anticipated mobility demands, ensuring a tailored fit for improved articulation and function.
Is the ACS® LD FB Knee System intended for reuse, or is it meant to be used only once during surgery?
The ACS® LD FB Knee System is explicitly designed for single-use only, requiring sterile handling per standard orthopedic protocols. This aligns with common practices for implantable devices to minimize infection risks and ensure patient safety. Reuse is not recommended or supported by the manufacturer.
What storage and handling guidelines should be followed for the ACS® LD FB Knee System to maintain its integrity?
The ACS® LD FB Knee System must be stored and handled according to the manufacturer’s guidelines for implantable orthopedic devices, which typically include keeping components in their original, sealed packaging until use. The system should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality. Always follow the provided instructions to ensure the device remains suitable for surgical use.
Are there any MRI safety considerations for patients who receive the ACS® LD FB Knee System?
The manufacturer does not specify any MRI safety restrictions for the ACS® LD FB Knee System, but this does not imply MRI compatibility. Clinicians should verify current guidelines or consult the manufacturer for updates, as MRI safety can depend on specific imaging protocols and device materials. Always confirm with the manufacturer before subjecting patients to MRI scans post-implantation.
How does the modular design of the ACS® LD FB Knee System benefit surgeons during knee replacement procedures?
The modular design of the ACS® LD FB Knee System allows surgeons to select and assemble components—such as femoral, tibial, and polyethylene inserts—based on the patient’s anatomy and clinical needs. This flexibility enables precise customization of the knee joint replacement, particularly for patients with unicompartmental osteoarthritis and intact ligaments, to optimize alignment, congruency, and long-term function. The snap mechanism for the polyethylene insert also simplifies intraoperative assembly.
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: ACS® LD FB Knee System (K234044) — FDA 510(k) | Innolitics, PDF Implantcast GmbH ℅ Dave McGurl Director, Spine Regulatory Affairs MCRA ..., ACS® FB - implantcast, ACS LD Uni FB Knee System (K203341) - FDA 510 (k)
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 | K234044 | Class II | Active |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (5)
- FDA 510(k) K234044 24 fields · synced Sep 30, 2026
- FDA UDI b484b500-6d06-456b-b812-2a9372ca6f43 34 fields · synced May 30, 2026
- FDA UDI 5e37d124-11d8-4ea1-a429-7bd5ba28385c 33 fields · synced May 30, 2026
- EUDAMED f3d621d2-201b-4027-9936-2a01a1d8bf94 61 fields · synced Aug 1, 2026
- EUDAMED 86b42d9c-227e-4d31-9eae-9e0e4d36c9c9 61 fields · synced Sep 17, 2026