(57 days)
No
The device description and performance studies focus on mechanical properties and modifications to existing hardware, with no mention of AI or ML.
No
This device is for internal fixation (screws, plates, washers) used in surgical procedures like bone fusion and fracture treatment, not for therapy in the sense of rehabilitation or diagnosis.
No
Explanation: The device is described as a system for internal fixation and arthrodesis, which are surgical treatments, not diagnostic procedures. Its components (screws, washers, plates) are used to fix bones, not to diagnose conditions.
No
The device description explicitly states that the VariAx Foot system consists of physical components like screws, washers, and bone plates, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- VariAx Foot System Function: The VariAx Foot system is a surgical implant used for internal fixation of bones. It is physically placed inside the body to stabilize fractures, fusions, or osteotomies. It does not analyze biological samples.
The description clearly states its purpose is for surgical procedures involving bone fixation, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The VariAx Foot system is intended for use in internal fixation or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures include but are not limited to:
- Replantation
- Lag screw techniques
- Joint fusions
- Corrective osteotomies
- Treatment of fractures
Product codes
HRS, HWC
Device Description
VariAx Foot is a system used for internal fixation applications. VariAx Foot consists of self-taping locking and non-locking screws, as well as corresponding washers and compatible bone plates. Since its original submission (K063875), the screws of the system have been modified. The modification includes the addition of a cutting flute to the 2.7mm and 3.5mm locking and nonlocking screws and a change in the Tox head of the 2.7mm screws. The lengths of the 2.7mm diameter screws range from 8-50mm. The lengths of the 3.5mm diameter screws range from 10-70mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones including the fore, mid- and hind foot and ankle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing: An engineering rational has been provided to demonstrate equivalence of the subject device to the predicate with respect to insertion torque and pull out force. LAL testing was performed to establish that the subject devices meet the less than 20 EU/device limit.
Clinical Testing: Clinical Testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Stryker Foot Plating System (K063875)
Reference Device(s)
VariAx Elbow System (K101056)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2019
Stryker GmbH Jemin Dedania Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K192675
Trade/Device Name: VariAx Foot Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 24, 2019 Received: September 26, 2019
Dear Jemin Dedania:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192675
Device Name VariAx Foot
Indications for Use (Describe)
The VariAx Foot system is intended for use in internal fixation or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures include but are not limited to:
- · Replantation
- · Lag screw techniques
- · Joint fusions
- · Corrective osteotomies
- Treatment of fractures
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | |
|---|---|
| Proprietary Name: | VariAx Foot |
| Common Name: | Screw, Fixation, Bone |
| Plate, Fixation, Bone | |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Single/Multiple component metallic bone fixation | |
| appliances and accessories | |
| Regulation Number: | 21 CFR 888.3030, 21 CFR 888.3040 |
| Product Code: | HWC (Screw, Fixation, Bone/Washer) |
| HRS (Plate Fixation, Bone) | |
| Device Class: | Class II |
| Sponsor: | Stryker GMBH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Jemin Dedania |
| Associate Manager Regulatory Affairs | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201)-831-6461 | |
| Fax: (201) - 831-6500 | |
| Additional Contact Person: | Christine Adib |
| Regulatory Affairs Intern | |
| Date Prepared: | 08/26/2019 |
| Primary Predicate: | Stryker Foot Plating System (K063875) |
| Reference Predicate Device: | VariAx Elbow System (K101056) |
Description
VariAx Foot is a system used for internal fixation applications. VariAx Foot consists of self-fapping locking and non-locking screws, as well as corresponding washers and compatible bone plates. Since its original submission (K063875), the screws of the system have been modified. The modification includes the addition of a cutting flute to the 2.7mm and 3.5mm locking and nonlocking screws and a change in the Tox head of the 2.7mm screws. The lengths of the 2.7mm
4
diameter screws range from 8-50mm. The lengths of the 3.5mm diameter screws range from 10-70mm.
Indications for Use
VariAx Foot is intended for use in internal fixation, reconstruction or anthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to:
- . Replantation
- lag screw techniques
- joint fusions ●
- . corrective osteotomies
- treatment of fractures.
Summary of Technologies
A comparison of the systems demonstrated that the subject VariAx Foot is substantially equivalent to the Stryker Foot Plating System (K063875) in regard to intended use, material, design, and operational principles.
Non-Clinical Testing
An engineering rational has been provided to demonstrate equivalence of the subject device to the predicate with respect to insertion torque and pull out force.
LAL testing was performed to establish that the subject devices meet the less than 20 EU/device limit.
Clinical Testing
Clinical Testing was not required for this submission.
Conclusion
The subject VariAx Foot system described in this submission has the same indications, intended use, target patient population, technological characteristics, and materials as the predicate devices. The subject VariAx Foot system is substantially equivalent to the predicate Stryker Foot Plating System (K063875).