The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.

Indications include:

compression fractures .
intra-articular and extra-articular fractures ●
. displaced fractures

Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

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 Distal Radius Plating, which was cleared in K04022, as the Universal Distal Radius System. The subject plate consists of distal radius fragment specific plates (lateral and dorsal medial). The subject components will be available sterile and non-sterile. The VariAx Distal Radius Plating System consists of multiple internal fixation plates in varying lengths and widths. The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, K132502 and K140769.

AI/ML Overview

The provided document describes a 510(k) submission for a line extension to a bone plating system, specifically the VariAx Distal Radius Plating System. This type of submission is for medical devices that are "substantially equivalent" to predicate devices already on the market. Therefore, the "acceptance criteria" and "study" are focused on demonstrating this substantial equivalence through non-clinical testing, rather than a clinical study establishing efficacy or diagnostic performance as would be expected for an AI/ML device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Device)	Reported Device Performance (Reference Standard)
Mechanical Performance: Meet "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008" for the worst-case subject plates.	The non-clinical laboratory testing "[demonstrated] that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the TriMed Bone Plates (K060041)."
Intended Use Equivalence: Same intended use as predicate devices.	The device is intended for internal fixation of small bone fractures, primarily including distal radius fractures, similar to the TriMed Wrist Plates (K060041).
Operational Principles Equivalence: Similar operational principles for use.	The device is similar to the TriMed Wrist Plates (K060041) in regards to operational principles for use for internal fixation for fractures of the bones in the distal radius.

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

Sample Size for Test Set: The document mentions "worst case subject plates" were tested. It does not specify the exact number of plates or samples tested, but implies that representative samples deemed "worst case" were selected for mechanical testing.
Data Provenance: The testing was "non-clinical laboratory testing." The document does not specify the country of origin of the data beyond implying it was conducted to ASTM standards, which are international standards. The testing was retrospective in the sense that it evaluates the manufactured product against established standards and a predicate device, not in the context of a prospective patient study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for this device's acceptance is based on engineering standards (ASTM F382-99:2008) and comparison to a legally marketed predicate device, not on expert medical consensus on diagnostic outcomes or interpretations.

4. Adjudication Method for the Test Set

This is not applicable. There was no expert-based ground truth to adjudicate for this type of submission. The performance was assessed against engineering standards.

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

This is not applicable. This submission is for a physical medical device (bone plating system), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is:

Engineering Standards: Compliance with "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
Predicate Device Performance: Demonstrating substantial equivalence to the mechanical, intended use, and operational principles of the TriMed Wrist Plates (K060041).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Manufacturing processes are validated, but this isn't referred to as a "training set" in the context of AI/ML.

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

This is not applicable for the same reason as point 8. There is no training set mentioned in the context of an AI/ML algorithm.

Summary

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510(k) Summary

JUL 1 8 2014

Proprietary Name:

VariAx Distal Radius Plating System

Common Name:

Bone Plates Bone Screws

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

Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040

Regulatory Class:

Product Codes:

Sponsor:

Contact Person:

Class II

HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bon

Stryker Leibinger GmbH & Co.KG

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:

May 29, 2014

Description

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Intended Use

The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.

Indications for Use

Indications include:

compression fractures .
intra-articular and extra-articular fractures ●
. displaced fractures

Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

Summary of Technologies

Device comparison showed that subject device is substantially equivalent to the TriMed Wrist Plates (K060041) in regards to intended use, and operational principles for use for internal fixation for fractures of the bones in the distal radius.

Non-Clinical Test

Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the TriMed Bone Plates (K060041), The following testing was performed "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The subject devices which are being added to the VariAx Distal Radius Plating System are substantially equivalent to the predicate device 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 18, 2014

Stryker Leibinger GmbH & Co.KG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K141430 Trade/Device Name: VariAx Distal Radius 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: May 29, 2014 Received: May 30, 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, 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 Acts 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 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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K141430 page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k) Number (if known) K141430

Device Name

VariAx Distal Radius Plating System

Indications for Use (Describe)

The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.

Indications include:

· compression fractures
· intra-articular and extra-articular fractures
· displaced fractures

Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, and malunions.

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 Heath (CDRH) (Signature)

Elizabet标办公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 Ilme 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 Food and Drug Administration Office of Chiaf Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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.

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.