The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including: . Replantation . Joint fusions . Corrective osteotomies . Osteopenic bone

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 System. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the foot and ankle. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 14-70mm in length.

AI/ML Overview

The provided text does NOT describe acceptance criteria or a study that proves the device meets acceptance criteria related to clinical performance or diagnostic accuracy.

Instead, the document details a 510(k) premarket notification for a bone plate system (VariAx 2 System). This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through non-clinical testing for mechanical performance, rather than clinical efficacy studies.

Here's a breakdown based on the information provided and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Type	Acceptance Criteria (Specific Values/Thresholds)	Reported Device Performance (Specific Values/Results)
Non-clinical - Construct Fatigue Strength	Not explicitly stated in the document (implied to be similar to predicate devices)	Testing demonstrated substantial equivalence to predicate devices. (Specific values for fatigue strength are not provided in this summary).
Clinical Performance	Not applicable for this submission type; no clinical criteria were established or evaluated.	Not applicable; clinical testing was not required for this submission.

2. Sample size used for the test set and the data provenance:

Test Set (Non-clinical): The document states "Construct Fatigue Strength Testing" was performed. However, it does not specify the sample size of the constructs tested (e.g., number of plates/screws).
Data Provenance: The document does not specify the country of origin for the non-clinical testing data. It only states "Non-clinical laboratory testing was performed on the VariAx 2 System components".
Retrospective/Prospective: Non-clinical testing of this nature is neither retrospective nor prospective in the same sense as patient studies; it's laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This information is not relevant as no clinical test set or ground truth based on expert review was established or used for this submission. The "ground truth" for the non-clinical testing would be the physical properties and performance measured in the lab.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable: No clinical test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable: This device is a bone plate system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Non-clinical: The "ground truth" for the non-clinical testing would be the physical and mechanical properties of the device constructs (e.g., load to failure, cycles to failure) measured according to established engineering standards (though the specific standards are not detailed in this summary).
Clinical: No clinical ground truth was established as no clinical testing was required.

8. The sample size for the training set:

Not Applicable: As this is a medical implant and not a machine learning model, there is no "training set" in the context of AI.

9. How the ground truth for the training set was established:

Not Applicable: See point 8.

In summary: The provided document is a regulatory submission for a physical medical device (bone plates) that relies on demonstrating substantial equivalence through non-clinical mechanical testing. It explicitly states "Clinical testing was not required for this submission." Therefore, most of the requested information pertaining to clinical studies, human readers, AI, or clinical ground truth is not present and not relevant to this specific regulatory pathway.

Summary

{0}------------------------------------------------

APR 0 3 2014

Proprietary Name:

VariAx 2 System

Common Name:

Bone plates

Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030

Regulatory Class:

Class II

Product Codes:

87 HRS: Plate, Fixation, Bone

Sponsor:

Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland

Contact Person:

· Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com

Date Prepared:

February 11, 2014

Description

{1}------------------------------------------------

Intended Use

The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients.

Indications

The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:

. Replantation
Joint fusions .
Corrective osteotomies ●
Osteopenic bone .

Summary of Technologies

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate devices:

K063875 Stryker Foot Plating System ◆
K100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System .
K101240 DePuy ALPS Small Bone Locked Plating System .
K091214 Synthes 2.4mm/2.7mm Variable Angle (VA)- LCP Forefoot/ Midfoot . System

Non-Clinical Testing

Non-clinical laboratory testing was performed on the VariAx 2 System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing.

The following testing was performed

Construct Fatigue Strength Testing .

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The VariAx 2 System is substantially equivalent to the predicate device identified in this premarket notification.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, rendered in black.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 3, 2014

Stryker Trauma AG Ms. Estela Celi Specialist Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K140376

Trade/Device Name: VariAx 2 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: February 11, 2014 Received: February 14, 2014

Dear Ms. Celi:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Estela Celi

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K140376

Device Name: VariAx 2 System

Indications for Use:

The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:

. Replantation
. Joint fusions
Corrective osteotomies .
. Osteopenic bone

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet同必Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 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.