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 document is a 510(k) Pre-Market Notification from the FDA regarding the "Ultima HA Coated Half Pins And Wire" manufactured by Vilex in Tennessee, Inc. It details the substantial equivalence review process, but it DOES NOT contain information about specific acceptance criteria, a study that proves the device meets those criteria, or performance metrics.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Ultima HA Coated Half Pins and Wires by Vilex, K132820). The rationale for substantial equivalence is based on:

Indications for Use: The current device has the same intended uses as the predicate.
Technological Characteristics: The device has similar technological characteristics (e.g., material, sizes, design) to the predicate.
Material of Construction: The materials used are the same.
Analysis Data: General analysis data is mentioned as supporting safety and effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance as it is not present in the provided text.

Based on the provided text, I can only provide the following:

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

Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics. It establishes substantial equivalence by comparing the device's characteristics and indications for use to a predicate device.

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

Not Available. No specific test set, sample size, or data provenance is mentioned for performance evaluation in this 510(k) summary. The document relies on similarity to a predicate device and material/analysis data.

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)

Not Applicable. No ground truth establishment related to a test set for performance evaluation is mentioned.

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

Not Applicable. No test set or related adjudication method is mentioned.

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

Not Applicable. This device is a medical implant (bone fixation fastener), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

Not Applicable. This device is a physical medical implant, not an algorithm.

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

Not Available/Not Applicable. The concept of "ground truth" as it applies to performance evaluation of a diagnostic or AI device is not relevant here. The substantial equivalence relies on demonstrating that the device is as safe and effective as a legally marketed predicate through design, material, and intended use similarities.

8. The sample size for the training set

Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

Not Applicable. As above, no training set or ground truth for it is relevant to this device.

Summary of what is available from the document:

Device Name: Ultima HA Coated Half Pins and Wires
Predicate Device: Ultima HA Coated Half Pins and Wires by Vilex (K132820)
Basis for Substantial Equivalence: Similar indications for use, technological characteristics (materials, sizes, design), and general analysis data.
Indications for Use:
1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities
Material: Medical grade stainless steel coated with Hydroxyapatite (HA).
Safety Testing: Pyrogen testing was conducted and confirmed the device is non-pyrogenic.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

February 13, 2017

Vilex in Tennessee, Inc. % Dr. Abraham Lavi Consultant Vilex, Inc. 8374 Market Street, #167 Lakewood Ranch, Florida 34202

Re: K163487

Trade/Device Name: Ultima HA Coated Half Pins And Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW Dated: November 21, 2016 Received: December 12, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/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,

Mark N. Melkerson -S

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/2/Picture/0 description: The image shows the word "VILEX" in red font inside a red rectangular box. The letters are bold and sans-serif. There is a registered trademark symbol to the right of the letter X.

111 Moffitt Street • McMinnville, TN 37110 Toll Free 800-521-5002 • Phone 931-474-7550 • Fax 931-474-7551 Email: info@vilex.com • www.vilex.com

"We'll Wait on You Hand and Foot"

INDICATIONS FOR USE

510(k) NUMBER: K163487

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

X Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (DOE)

Page 1 of 1

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Image /page/3/Picture/0 description: The image shows the logo for VILEX, which is displayed in red font. The letters are bold and stylized, with the 'V' having a sharp angle and the 'X' extending beyond the other letters. The logo is enclosed in a red rectangular border, and a small circled 'R' symbol is present near the bottom right corner of the 'X'.

"We'll Wait on You Hand and Foot"

Vilex in Tennessee, Inc.

111 Moffitt Street • McMinnville, TN 37110 Toll Free 800-521-5002 • Phone 931-474-7550 • Fax 931-474-7551 Email: info@vilex.com • www.vilex.com

510(k) Summary K163487

Sponsor:	Vilex in Tennessee, Inc.
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 metallic bone fastener
Product Code:	JDW/Orthopedics, Class II
Predicate Devices:	Ultima HA Coated Half Pins and Wires by Vilex (K132820)

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
1. Correction of Bone Deformity in Upper & Lower Extremities

Technological Characteristics:

The technological characteristics for the Modified Ultima HA Coated Half Pins and Wires are the same as the characteristics of the predicate devices. All of the sizes included in the Vilex Modified 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. In addition, pyrogen testing has been conducted and has confirmed that the device is non-pyrogentic.

Substantial Equivalence

The design features of the Modified Ultima HA Coated Half Pins and 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, and sizes. The safety and effectiveness of the Modified Ultima HA Coated Half Pins and Wires are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Modified Ultima HA Coated Half Pins and Wires are substantially equivalent to the noted predicate devices.

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Vilex in Tennessee, Inc.

Image /page/4/Picture/2 description: The image shows the word "VILEX" in red font. The letters are stylized, with the top of the "V" extending over the "I" and "L". The word is enclosed in a red rectangular border. There is a registered trademark symbol to the bottom right of the word.

"We'll Wait on You Hand and Foot"

111 Moffitt Street • McMinnville, TN 37110 Toll Free 800-521-5002 • Phone 931-474-7550 • Fax 931-474-7551 Email: info@vilex.com • www.vilex.com

510(k) Summary K163487

Conclusions

While the Modified 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 Modified 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.

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.