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:
- Intra-articular and extra-articular fractures;
- Displaced fractures;
- Reconstruction procedures;
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,
- Displaced and compression fractures of the Distal Radius;
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle;
- Reconstruction procedures in the Foot & Ankle and Distal Radius:
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:
- Single, segmental and comminuted fractures;
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle:
- Normal bone density or osteopenic bone.

Device Description

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, 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 VariAx 2 System is a medical device designed for internal bone fixation. Its acceptance was determined through non-clinical laboratory testing, demonstrating substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria	Reported Device Performance
Screw Pull-Out Testing	Performance comparable to predicate devices	Substantially equivalent to predicate devices
Screw Shear-Off Testing	Performance comparable to predicate devices	Substantially equivalent to predicate devices
Screw Insertion Torque Testing	Performance comparable to predicate devices	Substantially equivalent to predicate devices
Static Cantilever Bending of Locking Mechanism	Performance comparable to predicate devices	Substantially equivalent to predicate devices
Dynamic Fatigue Plate-Screw Construct Testing	Performance comparable to predicate devices	Substantially equivalent to predicate devices

Note: The document does not provide specific numerical values for the acceptance criteria or reported performance. The "acceptance criteria" and "reported device performance" are inferred from the statement "Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing."

2. Sample Size and Data Provenance for Test Set:

Sample Size: The document does not specify the sample size used for each non-clinical test.
Data Provenance: Not applicable as the testing was non-clinical laboratory testing. The country of origin for the sponsor, Stryker Trauma AG, is Switzerland.

3. Number and Qualifications of Experts for Ground Truth:

Not applicable. The regulatory pathway for this device (510(k)) focuses on substantial equivalence through non-clinical testing for fracture fixation systems, not on human expert assessment for image interpretation or diagnosis. Therefore, no experts were used to establish ground truth in the context of image interpretation.

4. Adjudication Method for Test Set:

Not applicable. This was a non-clinical device testing study, not a clinical study involving human judgment or interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states, "Clinical testing was not required for this submission."

6. Standalone Performance Study:

Yes, in a way. The non-clinical laboratory tests assess the performance of the device components (screws and plate-screw constructs) in isolation, under controlled laboratory conditions, to determine their mechanical properties and functional equivalence to predicate devices. This represents an "algorithm only without human-in-the-loop performance" in the context of a physical device's mechanical integrity.

7. Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria was based on engineering and mechanical performance benchmarks established by predicate devices and recognized industry standards for bone fixation appliances. These benchmarks are inherently quantitative and objective, derived from physical testing.

8. Sample Size for the Training Set:

Not applicable. This device is a physical bone fixation system, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of medical device submission.

Summary

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510(k) Summary

Proprietary Name: VariAx 2 System

Common Name: Bone Screws

Classification Name and Reference:

Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030

Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040

Regulatory Class:

Class II

Product Codes:

Sponsor:

Contact Person:

HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bone HTN: Washer, Bolt Nut

Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland

Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 elijah.wreh@stryker.com Phone: 201-831-5691 Fax: 201-831-4691

Date Prepared:

August 7, 2013

Description

This Traditional 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, 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.

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Intended Use

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:
- Compression fractures: O
- O Intra-articular and extra-articular fractures;
- 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
T 10 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; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. 0

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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:

Table 1: Predicate devices

510(k) Number
K080667	VariAx Distal Radius Torx Screws
K100271	VariAx Distal Radius Line Extension of XXL Plates
K063875	Stryker Foot Plating System
K081284	VariAx Distal Fibula Plate
K102282	VariAx Locked Plating System Line Extension for Additionof Fibula Straight Plates
K073527	VariAx Elbow System
K101056	VariAx Elbow System
K113760	VariAx Clavicle System
K130009	VariAx 2 Compression Plating System
K000636	Stryker Trauma Plating System

Non-Clinical Testing

Non-clinical laboratory testing was performed for 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

. Screw Pull-Out Testing
Screw Shear-Off Testing .
. Screw Insertion Torque Testing
. Static Cantilever Bending of Locking Mechanism
. Dynamic Fatigue Plate-Screw Construct Testing

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

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

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

October 23, 2013

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

Re: K132502

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: August 7, 2013 Received: August 9, 2013

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. Iisting 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

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Page 2 - Mr. Elijah N. Wreh

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Image /page/4/Picture/7 description: The image shows the name "Erin Meith" in a stylized font. The letters are bold and black, with a unique design that makes them stand out. The name is likely a logo or a personal branding element. The font choice adds a modern and artistic touch to the name.

for

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

Enclosure

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Indications for Use

510(k) Number (if known): _ K132502

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; O
- 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; 0
- o Reconstruction procedures in the Foot & Ankle and Distal Radius:
T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and o Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna: 0
- 0 Single, segmental and comminuted fractures;
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle: 0
- Normal bone density or osteopenic bone. o

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (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

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.