The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:

osteotomies, mal-unions, and non-unions .
single, segmental, and comminuted fractures .
normal bone density and osteopenic bone .

Device Description

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.

AI/ML Overview

This document describes a 510(k) submission for the VariAx 2 Compression Plating System, a medical device for internal fixation of bone fractures.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Device must be substantially equivalent to the predicate device (K130009) in intended use, materials, and performance characteristics.	Non-clinical testing demonstrated that the modified plates are substantially equivalent to the previously cleared K130009.
Mechanical Performance	(Implied) The modified plates must maintain adequate mechanical strength and stability.	Testing was performed for "Compression Plates Screw Through Compression Hole 0° and 15° Angulation with VariAx Screws." The results supported substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load, displacement) and their corresponding performance values are not explicitly stated in this document.

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

Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing" and "The following testing was performed: - Compression Plates Screw Through Compression Hole 0° and 15° Angulation with VariAx Screws." This implies physical testing of device samples rather than a data-driven test set for an algorithm. The number of physical units tested is not provided.
Data Provenance: Not applicable in the context of an AI/algorithm-based device. This is a traditional medical device submission based on mechanical testing.

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

Not applicable. Ground truth as typically understood for AI models (e.g., expert annotations) is not relevant for this type of mechanical device submission.

4. Adjudication method for the test set

Not applicable. This is a traditional medical device submission based on mechanical testing, not a clinical study involving human readers or adjudicators for a test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone plate and screw system, not an AI or imaging diagnostic device.

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

Not applicable. This is a mechanical medical device, not an algorithm.

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

For this mechanical device, the "ground truth" would be established by engineering specifications and mechanical testing standards. The performance of the modified plates (e.g., strength, stiffness, fatigue resistance) is measured against established benchmarks and compared to the predicate device's performance. The document only broadly states "testing demonstrated that the modified plates are substantially equivalent to the previously cleared K130009," without detailing the specific engineering metrics or benchmarks.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an algorithm that requires a training set.

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

Not applicable. No training set was used.

Summary

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K140565

510(k) Summary

Proprietary Name:	VariAx 2 Compression Plating System
Common Name:	Bone platesBone Screws
Classification Name and Reference:	Single/multiple component metallic bone fixationappliances and accessories 21 CFR §888.3030
	Smooth or threaded metallic bone fixation fastener21 CFR §888.3040
Regulatory Class:	Class II
Product Codes:	87 HRS: Plate, Fixation, Bone87 HWC: Screw, Fixation, Bone
Sponsor:	Stryker Trauma AG

Contact Person:

CH-2545 Selzach Switzerland 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:

March 3, 2014

Bohnackerweg l

Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified VariAx 2 compression plate of the VariAx 2 Compression Plating System, previously cleared in K 130009. The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.

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K140565

Intended Use

The Stryker VariAx 2 Compression Plating System is internal fixation of bones in adult patients.

Indications

The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus. Clavicle. Distal tibia and Fibula for the following indications:

osteotomics, mal-unions, and non-unions .
single, segmental, and comminuted fractures .
normal bone density and 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 device:

. K130009 VariAx 2 Compression Plating System .

Non-Clinical Testing

Non-clinical laboratory testing was performed for the VariAx 2 Compression Plating System modified plates to determine substantial equivalence. Testing demonstrated that the modified plates are substantially equivalent to the previously cleared K 130009.

The following testing was performed

Compression Plates Screw Through Compression Hole 0° and 15° Angulation with . VariAx Screws

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

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

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its wings and body. The bird is oriented towards the right. Encircling the bird is text that reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

Food und Drug Administration 10903 New Hampshire Avenue Document Control Control - WO&G-Cib09 Silver Spring, MD 20993-0002

May 29, 2014

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

Re: K140565

Trade/Device Name: VariAx 2 Compression Plating 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 Dated: March 3, 2014 Received: March 5, 2014

Dear Ms. Celi:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 rethy promotice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuale commerce prior to May 28, 1976, the enactment date of the Medical Device American of God Days commerce provide in accordinate with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ion and Cosment Act (Act) that to not require approvate on the general controls provisions of the Act. The You may, therefore, mance the device, only of to me more registration, listing of general controls provisions of the revilabilions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contact librility addition. Please note: CDATT does not ovations must be truthful and not misleading.

If your device is classilied (see above) into cither class II (Special Controls) or classified on be If your device is classified (see above) into via regulations affecting your device and be may be subject to additional controls. "Internations. Title 21, Parts 800 to 898. In addition, FDA may found in the Code of Toderal Regoncerning your device in the Federal Register.

Please be advised that FDA `s issuance of a substantial equivalence determination dos not mean Please be advised that FDA s issuality of a substantiner with other requirements of the Act Inal IT/X has made a delemination that your correst by other Federal agencies. You must or any rederal statutes and regulations administed to: registration and listing comply with all the Act 3 requirements, moral device reporting (reporting of medical (2) CFR Part 807): labeling (21 CFR 803); good manufacturing practice requirements as scl

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Page 2 - Ms. Estela Celi

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-frée 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

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Indications for Use

510(k) Number (if known): _K140565

Device Name: VariAx 2 Compression Plating System

Indications for Usc:

The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius. Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:

osteotomies, mal-unions, and non-unions .
single, segmental, and comminuted fractures .
normal bone density and osteopenic bone .

Over-The-Counter Use Prescription Use X AND/OR (2) CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF 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.