The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:

Post-traumatic arthritis of the joints of the wrist .
Rheumatoid wrist deformities requiring restoration ●
Complex carpal instability ●
Post-septic arthritis of the wrist ●
Severe unremitting wrist pain related to motion
Brachial plexus nerve palsies
o Tumor resection
Spastic deformities

Device Description

VariAx 2 Wrist Fusion System is a fixation device that consists of plates with different design (standard bend, short bend, and straight) manufactured from Commercially Pure Titanium Grade 2 (ASTM F67). The plates will be available sterile and non-sterile. VariAx 2 Wrist Fusion System will be used with locking and non-locking screws (2.3mm, 2.7 and 3.5mm) previously cleared in K040022 (Stryker® Leibinger Universal Distal Radius System), K073527 (VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).

AI/ML Overview

This document describes a 510(k) premarket notification for the Stryker VariAx 2 Wrist Fusion System, a metallic bone fixation appliance. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device. The goal is to demonstrate that the new device is as safe and effective as the predicate.

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (VariAx 2 Wrist Fusion System)
Mechanical performance, specifically fatigue strength (as per ASTM F382-14)	Demonstrated to be equivalent in mechanical performance to the predicate device, the Synthes Wrist Fusion Plates (K000558). Testing included Dynamic Cantilever Bending Testing (fatigue strength).
Intended Use	The Stryker VariAx 2 Wrist Fusion System has the same intended use as the predicate device: indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications are also listed and are consistent with similar devices.
Material	The plates are manufactured from Commercially Pure Titanium Grade 2 (ASTM F67), which is a common material for bone implants and likely consistent with the predicate or other similar devices.
Design	The device consists of plates with different designs (standard bend, short bend, and straight) and is used with locking and non-locking screws (2.3mm, 2.7mm, and 3.5mm) and new and existing instruments. Device comparison demonstrated substantial equivalence to the Synthes Wrist Fusion Plates (K000558) in regards to design.
Operational Principles	Device comparison demonstrated substantial equivalence to the Synthes Wrist Fusion Plates (K000558) in regards to operational principles.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

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

Sample Size: The exact sample size for the mechanical testing is not specified in this document. It refers to "worst case subject plates," implying a representative selection, but the number is not given.
Data Provenance: The testing was "non-clinical laboratory testing." The country of origin of the data is not specified, but the sponsor is Stryker Trauma AG, located in Switzerland, and the contact person is in Germany. The testing itself would likely have occurred in a laboratory setting associated with the manufacturer or a contracted testing facility. It is prospective in nature, as it's testing performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a mechanical implant, not an AI/diagnostic device. As such, "ground truth" in the context of expert consensus for diagnostic interpretation is not applicable. The "ground truth" for the non-clinical testing is established by the ASTM F382-14 standard for metallic bone plates, which defines the acceptable mechanical properties. The "experts" in this context would be the engineers and technicians performing and interpreting the mechanical tests according to the standard. Their qualifications are not specified but would be in mechanical engineering or materials science.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically for clinical studies involving human interpretation or subjective endpoints. For non-clinical mechanical testing, there is no adjudication method mentioned or typically required in the same sense. The results are quantitative measurements against an established standard (ASTM F382-14). Discrepancies would be handled through repeat testing or calibration, not expert consensus.

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 MRMC study was done. This is a hardware implant device, not an AI or diagnostic software.

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

Not applicable. This section is for AI/software devices. The device is a physical bone fixation system.

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

For the non-clinical mechanical testing, the "ground truth" for evaluating the device's performance is:

Compliance with the ASTM F382-14 'Standard specification and test method for metallic bone plates'. This standard defines the acceptable mechanical properties, such as fatigue strength.

8. The sample size for the training set

Not applicable. This device is a hardware implant and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. See point 8.

Summary

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

June 24, 2015

Stryker Trauma Ag Dr. Heike Gustke Regulatory Affairs Specialist, Trauma & Extremities Prof.- Kuntscher- Str. 1-5 Schoenkirchen, 2432 DE Germany

Re: K151178

Trade/Device Name: Variax 2 Wrist Fusion 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 Dated: April 29, 2015 Received: May 4, 2015

Dear Dr. Heike Gustke:

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 (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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-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.

Mark N. Melkerson -S

Mark 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 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) K151178

Device Name

V ariAx 2 Wrist Fusion System

Indications for Use (Describe)

The Stryker VariAx 2 Wrist Fusion is indicated for wrist arthrodess and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:

specific indications include:

Post-traumatic arthritis of the joints of the
· Post-traumatic arthritis of the joints of the wrist · Rheumatoid wrist deformities requiring restoration
· Complex carpal instability
· Post-septic arthritis of the wrist
· Severe unremitting wrist pain related to motion
· Brachial plexus nerve palsies
· Tumor resection
· Spastic deformities

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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6 510(k) Summary

Proprietary Name:	VariAx 2 Wrist Fusion System
Common Name:	Bone Plates
Regulation Description:	Single/multiple component metallic bone fixation appliancesand accessories
Regulation Number:	21 CFR 888.3030
Product Code:	HRS (Plate, Fixation, Bone)
Device Class:	Class II
Sponsor:	Stryker Trauma AGBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Dr. Heike GustkeRegulatory Affairs SpecialistProf.-Kuentscher-Str. 1-524232 Schoenkirchen / Germanyheike.gustke@stryker.comPhone: +49 4348 702 637Fax: +49 4348 702 8637
Date Prepared:	April 29, 2015

Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 Wrist Fusion System.

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(VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).

Intended Use

The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis of fractures of other small bones of the carpus.

Indications for Use

Post-traumatic arthritis of the joints of the wrist .
Rheumatoid wrist deformities requiring restoration ●
Complex carpal instability ●
Post-septic arthritis of the wrist ●
Severe unremitting wrist pain related to motion
Brachial plexus nerve palsies
o Tumor resection
Spastic deformities

Summary of Technologies

Device comparison demonstrated that VariAx 2 Wrist Fusion System is substantially equivalent to the Synthes Wrist Fusion Plates (K000558) in regards to intended use, material, design, and operational principles.

Non-Clinical Test

Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. Mechanical testing was performed with compliance to ASTM F382-14 'Standard specification and test method for metallic bone plates'. Testing demonstrated that

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VariAx 2 Wrist Fusion System is equivalent in mechanical performance to the predicate device,

the Synthes Wrist Fusion Plates (K000558).

The following testing was performed:

Dynamic Cantilever Bending Testing (fatigue strength)

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

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

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.