This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

AI/ML Overview

This is a 510(k) summary for a medical device called "Ultima HA Coated Half Pins & Wires". The purpose of this summary is to demonstrate substantial equivalence to existing predicate devices, not to prove performance against specific acceptance criteria in a clinical study. Therefore, the information requested regarding acceptance criteria and study details is not present in this document.

Here's a breakdown of why the requested information cannot be provided from the given text:

This is a 510(k) submission: 510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with specific performance metrics and acceptance criteria.
Focus on Substantial Equivalence: The document explicitly states: "The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." This means the assessment is based on comparisons with existing devices, not a standalone performance study.
No mention of a clinical study for acceptance criteria: There is no description of a study designed to measure the device's performance against specific acceptance criteria. The "analysis data" mentioned likely refers to bench testing and material characterization, not patient data.

Therefore, I cannot provide the requested information for the following reasons:

A table of acceptance criteria and the reported device performance: Not present. The device is being cleared based on substantial equivalence, not a direct performance test against pre-defined criteria.
Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment activity from a clinical study is described.
Adjudication method: Not applicable.
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: Not applicable. This device is a bone fixation fastener, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The document concludes that "any differences that may exist do not significantly affect device safety and effectiveness" and that the device is "substantially equivalent to the predicate devices." This is the primary "proof" for a 510(k) submission of this nature.

Summary

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510(k) Summary K132820

JIII 2 3 2014

Sponsor:	Vilex in Tennessee, Inc.111 Moffitt St.McMinnville, TN 37110931-474-7550
Contact:	Abraham Lavi
Date Prepared:	June 16, 2014
Trade Name:	Ultima HA Coated Half Pins & Wires
Common Name:	Bone fixation fastener
Classification:	21 CFR 888.3040 - Smooth or threaded memtallic bone fastener
Product Code:	JDW/Orthopedics, Class II
Predicate Devices:	Smith & Nephew Jet-X Half Pins (HA Coated) (K023921, K033289)Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating(K974186) and Pins used with Mini Rail System (K955848)Stryker Apex Pins (K061493)Wright Medical Sidekick Rail Half Pins (K080071)SBi Mini Rail Half Pins by SBI (K093550)Treu Kirschner Wires by Treu-Instrumente GMBH (K083912)

Medical Facets Kirschner Wires by Medical Facets (K112727)

Description of Device:

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

Indications for Use:

The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
1. Rear & Mid-foot Foot Arthrodesis
1. Adult and Pediatric Leg Lengthening

Correction of Bone Deformity in Upper & Lower Extremities

Technological Characteristics:

The technological characteristics for the Ultima HA Coated Half Pins are Wires are the same as the characteristics of the predicate devices. All of the sizes included in the Vilex Ultima HA Coated Half Pin and Wire system are within the range of offerings of the predicate devices and the designs of the Vilex devices are similar to the predicate devices. The materials used to manufacture the Vilex Ultima devices are the same as those used to manufacture the predicate devices.

Substantial Equivalence

The design features of the Ultima HA Coated Half Pins & Wires are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are indications for use, material of construction, sizes, and shapes. The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by

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510(k) Summary K132820

the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Ultima HA Coated Half Pins and Wires are substantially equivalent to the noted predicate devices.

Conclusions

While the Ultima HA Coated Half Pins and Wires are not identical to the predicate devices, any differences that may exist do not significantly affect device safety and effectiveness. In addition, the differences do not add new or increased risks and complications. Therefore, it is concluded that the Ultima HA Coated Half Pins and Wires are substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE.

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Public Health Service

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

July 23, 2014

Vilex, Incorporated Dr. Abraham Lavi President 7214 Lake Forest Glen Lakewood Ranch, Florida 34202

Re: K132820

Trade/Device Name: Ultima HA Coated Half Pins and Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW Dated: June 19, 2014 Received: June 23, 2014

Dear Dr. Lavi:

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 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 - Dr. Abraham Lavi

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/Resourcesfor You/Industry/default.htm.

Sincerely yours, Lori A. Wigqins

for

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in large, bold, black letters, with the "EX" part of the word being stylized. Below the logo, there is text that reads "Manufacturer of Vilex TM bone implants, Power equipment & surgical instruments."

Phone: Fax: www.vilex.com

(931) 474-7550 (931) 474-7551

111 Moffitt Street McMinnville, TN 37110 USA E-mail: info@vilex.com

INDICATIONS FOR USE

510(k) NUMBER: K132820

DEVICE NAME: Ultima HA Coated Half Pins and Wires

INDICATIONS FOR USE:

The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
1. Rear & Mid-foot Foot Arthrodesis
1. Adult and Pediatric Leg Lengthening
1. Correction of Bone Deformity in Upper & Lower Extremities

Prescription Use ਮ (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (BOE) (ODE)

Page 1 of 1

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.