VariAx Foot Prosthesis by Stryker

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number08858251004395TL Basic UDI-DI 04546540538635UDI-DI	Date28 Jul 2026Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK192675	Date22 Nov 2019Cleared	StatusActive
United States	GUDID listing GUDID	Number04546540538635 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 08858251004395TL — open Devices and search for it
AccessGUDID record UDI-DI 04546540538635
FDA 510(k) database 510(k) number K192675

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 08858251004395TL registered 28 Jul 2026 Active
FDA 510(k) K192675 decided 22 Nov 2019 Active
FDA GUDID UDI-DI 04546540538635 listed 24 Sep 2015 Listed

Timeline

3 dated events

24 Sep 2015 Listed FDA GUDID 04546540538635
22 Nov 2019 Cleared FDA 510(k) K192675
28 Jul 2026 Registered EUDAMED 08858251004395TL

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name: Variax® Foot EUDAMED
VariAx GUDID
Generic name: Orthopaedic fixation plate, non-bioabsorbable
Device name: Variax Foot - Plate - Titanium - Class Iib - Sterile
Model / Ref / Catalog: 40-15032S, 08858251004395TL

Primary DI / UDI-DI: 04546540538635
Basic UDI-DI: 08858251004395TL
510(k) Number: K192675
FDA product code: HRS
EMDN code: P09120599 Bone fixation plates - other
GMDN term: Orthopaedic fixation plate, non-bioabsorbable

Device class: Class IIb EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 888.3030
EU registration type: Standard device
EU market of registration: Netherlands
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

Truth per registry

3 sources · 1 field differs

Field	EUDAMED	510(k)	GUDID
Device class	EUDAMED Class IIb	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Variax Elbow System K101056 13 May 2010 FDA record · FDA summary
Stryker Foot Plating System K063875 15 Mar 2007 FDA record

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Stryker GmbH

T2

Class IIb
Pins and Wires - Pin - Stainless Steel - Class Iib - Non Sterile

Class IIb
AxSOS

Class IIb
Hoffmann II - Handles and Adaptors - Class I - Non Sterile

Class I

See all devices from Stryker GmbH →

Properties

Supplied sterile
Single use
Implantable
Sutures
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (18, all answered No)