The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:

· Internal fracture fixation;
· Osteotomies;
· Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below:

· T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
- o Compression fractures;
- Intra-articular and extra-articular fractures; O
- Displaced fractures: o
- Reconstruction procedures; o
· T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, o
- Displaced and compression fractures of the Distal Radius: o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; O
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o
- Single, segmental and comminuted fractures; ਼
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. O

Device Description

This Special 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the VariAx 2 System. The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, ankle, distal tibia and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.

AI/ML Overview

The provided text describes a medical device, the VariAx 2 System, which consists of bone screws and instrumentation for internal fixation. This is a 510(k) submission seeking authorization to market the device. The core of the submission is to demonstrate that the VariAx 2 System is substantially equivalent to a previously cleared predicate device (K132502).

Here's the analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (K132502) in terms of: - Intended Use - Materials - Operational Principles - Design for use in internal bone fixation in adult patients	The subject device components are "substantially equivalent to the previously cleared VariAx 2 System (K132502) in regards to intended use, materials, and operational principles and similar with regard to design for use in for internal bone fixation in adult patients."
Performance Requirements (Safety & Effectiveness) as demonstrated through risk analysis and verification/validation.	"The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject components in comparison to the previously cleared predicate device (K132502). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices."
Compliance with ISO 14971: "Medical Devices – Application of risk management of medical devices."	A risk analysis was performed according to the requirements of ISO 14971.

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

The document does not provide details on specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The evaluation focuses on comparative analysis of the subject components against the predicate device rather than a new clinical study with human subjects or a defined "test set" in the context of AI testing. The "test set" implicitly refers to the physical components of the device undergoing non-clinical testing.

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

This information is not applicable in the context of this 510(k) submission for a bone fixation system. Ground truth and expert consensus are typically relevant for AI/medical imaging device evaluations where diagnostic accuracy is assessed against expert interpretations or pathological findings. Here, the assessment is based on engineering principles, materials science, and prior regulatory approvals.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods are used in studies involving subjective interpretation, often by human readers, to establish a definitive ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This type of study is specifically designed for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The VariAx 2 System is a physical bone fixation device, not an AI-powered diagnostic tool.

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

A standalone algorithm performance test is not applicable. The device is a physical medical implant, not a software algorithm.

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

The "ground truth" in this context refers to the established safety and effectiveness of the predicate device (K132502) and compliance with relevant engineering and quality standards. The non-clinical tests (material properties, mechanical performance, risk analysis) conducted on the subject device components serve to demonstrate that they meet these established benchmarks for a bone fixation system. There is no mention of expert consensus, pathology, or outcomes data to establish ground truth in the way it's used for AI or diagnostic devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device submission, which does not involve machine learning or AI.

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

This is not applicable for the same reason as point 8.

Summary

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510(k) Summary

Proprietary Name:	VariAx 2 System	APR 17 2014
Common Name:	Bone Screws
Classification Name and Reference:	Single/multiple component metallic bone fixation appliances andaccessories 21 CFR §888.3030
	Smooth or threaded metallic bone fixation fastener21 CFR §888.3040
Regulatory Class:	Class II
Product Codes:	HRS: Plate, Fixation, BoneHWC: Screw, Fixation, BoneHTN: Washer, Bolt Nut
Sponsor:	Stryker Trauma AGBohnackerweg 1CH-2545 SelzachSwitzerland
Contact Person:	Elijah N. WrehRegulatory Affairs Specialist325 Corporate DriveMahwah, NJ 07430elijah.wreh@stryker.comPhone: 201-831-5691Fax: 201-831-4691
Date Prepared:	March 26, 2014

Description

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Intended Use

ﻨﺔ.

The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.

Indications

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:

· Internal fracture fixation;
· Osteotomies;
· Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below:

· T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the
Distal Radius, in the treatment of:
- o Compression fractures;
- Intra-articular and extra-articular fractures; O
- Displaced fractures: o
- Reconstruction procedures; o
· T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, o
- Displaced and compression fractures of the Distal Radius: o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; O
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o
- Single, segmental and comminuted fractures; ਼
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. O

Substantial Equivulencv

The subject device components are substantially equivalent to the previously cleared VariAx 2 System (K 132502) in regards to intended use, materials, and operational principles and similar with regard to design for use in for internal bone fixation in adult patients.

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Non-Clinical Test

A risk analysis was performed according to the requirements of ISO 14971: "Medical Devices – Application of risk management of medical devices." The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject components in comparison to the previously cleared predicate device (K132502). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices.

Conclusion

The subject components of the VariAx 2 System are substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person embracing three wavy lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(166-G609 Silver Spring, MD 20993-0002

April 17, 2014

Stryker Trauma AG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K140769

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, HWC, HTN Dated: March 26, 2014 Received: March 27, 2014

Dear Mr. Wreh:

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. Ilisting 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

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Page 2 - Mr. Elijah N. Wreh

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/ReportalProblem/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.goy/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

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K140769 510(k) Number (if known):

Device Name: VariAx 2 System

Indications for Use:

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:

· Internal fracture fixation:
· Osteotomies:
· Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below:

· T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
- Compression fractures; 0
- Intra-articular and extra-articular fractures; 0
- Displaced fractures; 0
- Reconstruction procedures: 0
· T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; 0
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; ಂ
- Reconstruction procedures in the Foot & Ankle and Distal Radius; O
· T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o
- Single, segmental and comminuted fractures; 0
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; 0
- Normal bone density or osteopenic bone. O

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Divison of Orthopedic Devices

Page 48 of 242

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.