The VariAx Elbow Plating System is intended for fracture fixation of long bones.
The distal humerus plates are indicated for:
• intra-articular or extraarticular fractures of the distal humerus
• osteotomies
• nonunions
The olecranon plates are indicated for:
• intra-articular or extraarticular fractures of the proximal ulna
• osteotomies
• nonunions

Device Description

This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.

AI/ML Overview

This submission is for a medical device, the VariAx Elbow Plating System, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's a breakdown of the provided information, focusing on the relevant sections for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices in:	- Intended use
- Intended Use	- Design
- Design	- Materials
- Materials	- Operational principles
Mechanical performance as per ASTM F382-99 (reapproved 2008) "Standard Specification and Test Method for Metallic Bone Plates"	Testing demonstrated that the subject plates are substantially equivalent to the currently marketed predicate devices (VariAx Elbow Plating System K101056 and Synthes 3.5mm LCP Distal Humerus System K033995) in mechanical properties.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as this is a non-clinical, mechanical testing study. The document refers to testing "worst case subject plates," implying a representative sample of each new plate type was tested.
Data Provenance: The testing was "Non-clinical laboratory testing" performed by Stryker Trauma AG. The country of origin of the data is not specified but is presumably where Stryker Trauma AG conducts its R&D and testing. It is prospective testing designed to evaluate the new plates.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to a non-clinical mechanical performance study. Ground truth is established by the ASTM F382-99 standard and the mechanical properties of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. This was mechanical testing against a standard and predicate device performance.

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

Not applicable. This is a medical device for fracture fixation, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. There is no algorithm for this device. The "standalone" performance here refers to the mechanical performance of the device itself. The study confirms that the device's mechanical properties (strength, fatigue, etc.) meet the specified standard and are equivalent to predicate devices.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

ASTM F382-99 (reapproved 2008) "Standard Specification and Test Method for Metallic Bone Plates": This standard defines the acceptable mechanical properties for bone plates.
Performance of Legally Marketed Predicate Devices: Specifically, the VariAx Elbow Plating System (K101056) and the Synthes 3.5mm LCP Distal Humerus System (K033995) were used as benchmarks for substantial equivalence comparison.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and does not involve a "training set" in that context. The "training" in this case refers to the engineering design and manufacturing processes that result in the device.

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

Not applicable. There is no "training set" ground truth in the context of an AI/ML device. The design and manufacturing of the device are based on established engineering principles, biomechanical understanding of bone fixation, and compliance with materials standards (e.g., ASTM F136 and ASTM F67 for titanium alloys).

Summary

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510(k) Summary

JUL 2 2 2014

Proprietary Name:	VariAx Elbow Plating System
Common Name:	Plate, Fixation, Bone
Classification Name and Reference:	Single/multiple component metallic bone fixation applianceand accessories 21 CFR §888.3030
Regulatory Class:	Class II
Product Codes:	HRS: Plate, Fixation, Bone
Sponsor:	Stryker Trauma AG
Contact Person:	Elijah N. WrehRegulatory Affairs Specialist325 Corporate DriveMahwah, NJ 07430elijah.wreh@stryker.comPhone: 201-831-5691Fax: 201-831-4691
Date Prepared:	June 20, 2014

Description

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Intended Use

The VariAx Elbow Plating System is intended for fracture fixation of long bones.

Indications for Use

The VariAx Elbow Plating System is intended for fracture fixation of long bones. The distal humerus plates are indicated for:

intra-articular or extraarticular fractures of the distal humerus .
osteotomies .
nonunions .

The olecranon plates are indicated for:

intra-articular or extraarticular fractures of the proximal ulna .
osteotomies ●
. nonunions

Summary of Technology

The device comparison showed that the subject device is substantially equivalent in intended use, design, materials and operational principles to the VariAx Elbow Plating System (K101056) and the Synthes 3.5mm LCP Distal Humerus System (K033995) for fracture fixation of long bones.

Non-Clinical Testing

Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The following testing was performed:

"Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-. 99 (reapproved 2008)
Testing demonstrated that the subject plates are substantially equivalent to the currently marketed predicate devices.

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The subject VariAx Elbow Plating System is substantially equivalent to the predicate devices identified throughout this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 22, 2014

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

Rc: K141677

Trade/Device Name: VariAx Elbow Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: June 20, 2014 Received: June 23, 2014

Dear Mr. Wrch:

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

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Page 2 - Mr. Elijah N. Wreh

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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/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 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/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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number (if known)	K141677
Device Name	VariAx Elbow Plating System
Indications for Use (Describe)	The VariAx Elbow Plating System is intended for fracture fixation of long bones.The distal humerus plates are indicated for:• intra-articular or extraarticular fractures of the distal humerus• osteotomies• nonunionsThe olecranon plates are indicated for:• intra-articular or extraarticular fractures of the proximal ulna• osteotomies• nonunions
Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Elizabeth Frank -S
Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, Including suggestions for reducing this burden, to:

Department of Health and Human Services
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Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)	Page 1 of 1	PSC Publishing Services (301) 433-6740 EF
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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.