VariAx Foot
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Stryker GmbH
Identity
- Trade Name
- VARIAX® FOOT EUDAMEDVariAx FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- VARIAX FOOT - PLATE - TITANIUM - CLASS IIB - STERILE EUDAMEDRECTANGULAR PLATE WITH LOCKING HOLE FDA UDI
- Model / Reference
- 40-15032S EUDAMEDFDA UDI08858251004395TL EUDAMED
- Description
- RECTANGULAR PLATE WITH LOCKING HOLE FDA UDI
Identifiers
- Catalog Number
- 40-15032S FDA UDI
- Primary DI / UDI-DI
- 04546540538635 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251004395TL EUDAMED
- 510(k) Number
- K192675 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands 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
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The VariAx Foot is a Foot Prosthesis designed to restore mobility and function for below-knee amputees. It is a modular, customizable prosthetic foot system that provides dynamic response and energy return during gait, improving stability and natural movement.
This device is supplied as a reusable component, intended for use in clinical and home settings by certified prosthetists. It is not sterile and requires proper fitting and adjustment by a qualified professional. The VariAx Foot is authorized under FDA 510K and MDR, adhering to regulatory standards for orthopedic prosthetics. Sizes and configurations are tailored to individual patient anatomy.
Frequently asked questions
Is the VariAx Foot designed for single-use or can it be reused?
The VariAx Foot is supplied as a reusable component, intended for long-term use by below-knee amputees. It is not sterile and requires proper fitting, adjustment, and maintenance by a certified prosthetist to ensure optimal performance and hygiene in both clinical and home settings.
What types of settings can the VariAx Foot be used in, and who should fit it?
The VariAx Foot is intended for use in both clinical (e.g., hospitals, prosthetics clinics) and home settings. It must be fitted and adjusted by a qualified prosthetist to ensure proper alignment and functionality, as it is a modular system tailored to individual patient anatomy.
How is the VariAx Foot customized to fit different patients?
The VariAx Foot is a modular, customizable prosthetic foot system designed to adapt to individual patient anatomy. Its sizes and configurations are tailored through professional fitting by a certified prosthetist to optimize mobility, stability, and natural movement for below-knee amputees.
Does the VariAx Foot require any special storage conditions?
While the VariAx Foot itself does not specify unique storage conditions in the provided data, as a reusable prosthetic component, it should be stored in a clean, dry environment to prevent damage or contamination. Proper maintenance and cleaning protocols, as recommended by the manufacturer, should be followed to ensure longevity and hygiene.
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 | K192675 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (3)
- FDA 510(k) K192675 24 fields · synced Sep 18, 2026
- FDA UDI 602a17f6-ed91-4b36-832d-fe5997267415 35 fields · synced May 30, 2026
- EUDAMED 67b37e5f-b2b9-4b79-9d2d-aa1de3d6240c 61 fields · synced Sep 17, 2026