The Verticor K-Wire System is intended for use in fixation of bone fractures, fusion of joints or bone reconstruction, for osteotomies in the presence of adequate immobilization and as guide pins for insertion of other implants.

Device Description

K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. To ensure the multi-use of these devices, many different models are available. Threaded K-wires are available for situations where backing out of the pin is undesirable.

AI/ML Overview

The provided text describes a 510(k) Summary for the Verticor K-Wire System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed acceptance criteria and a study to prove that a device meets those criteria in the same way one would for a novel device or software.

In the context of a 510(k), "acceptance criteria" are implied by the features and characteristics that need to be demonstrated as substantially equivalent to the predicate device. The "study that proves the device meets the acceptance criteria" is the substantial equivalence comparison and non-clinical testing rather than a traditional clinical study with defined performance metrics for the novel device.

Here's an analysis based on the provided text, structured to answer your questions as best as possible within the constraints of a 510(k) summary for a K-wire system:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for K-wires in a 510(k) filing primarily revolves around demonstrating that the new device is as safe and effective as its predicate. This is achieved by showing comparable design, materials, function, and intended use. The table below outlines the key comparative features and notes on the Verticor K-Wire System's performance in relation to these accepted characteristics.

Feature / Acceptance Criteria	Verticor K-Wire System Performance (compared to predicate)
Material (316L stainless steel per ASTM F138)	Meets 316L stainless steel specification, identical to predicates.
Length (mm) (within predicate range)	150 up to 450mm (overlaps with KMedic's 102-305mm and SMT Schilling's 60-500mm). Falls within acceptable range.
Diameter (mm) (within predicate range)	0.7 up to 1.6mm (identical to KMedic's range, within SMT Schilling's 0.6-6.35mm range). Falls within acceptable range.
Surface (smooth, threaded, or partial)	Complete or partial smooth and/or threaded (similar to predicates).
Tip Geometry (diamond, trocar, round, flat, spherical)	Diamond or trocar point, round, flat, with or without spherical shape (similar to predicates).
Sterility	Non-sterile, sterilized in hospital (identical to predicates).
Function (hold bone fragments, provide anchor for skeletal traction)	Stated function is identical to predicates.
Intended Use (fixation of bone fractures, fusion of joints or bone reconstruction, osteotomies, guide pins)	Stated intended use is identical to predicates.

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

Sample Size: Not applicable in the traditional sense of a clinical or performance study with a test set. This 510(k) relies on a comparison to predicate devices, supported by non-clinical verification of material and dimensional specifications.
Data Provenance: Not applicable for a comparative equivalence submission of this nature. The "data" are the specifications and characteristics of the predicate devices already legally marketed in the U.S. and the specifications of the new device.

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

Not applicable. Ground truth, in this context, would be the established safety and effectiveness of the predicate devices, which is accepted by their prior 510(k) clearances. No new "ground truth" was established by experts for the Verticor K-Wire System for the purpose of this submission beyond the regulatory review process itself.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a K-wire, which is a physical surgical instrument, not an AI or imaging diagnostic tool that would typically undergo such a study.

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

Not applicable. The device is a physical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (KMedic External Fixation Devices K030336 and SMT Schilling Kirschner/Guide Wires K100736), as accepted by their prior FDA clearances. The Verticor K-Wire System aims to demonstrate substantial equivalence to this pre-existing "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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510(k) Summary for the Verticor K-Wire System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations FFB 2 8 2011 the following 510(k) summary is submitted for the Verticor K-Wire System

Date Prepared: 12/31/2010

1. Submitter: Contact Person: Verticor, LTD J.D. Webb 600 N. Marienfeld Street, Suite 350 The OrthoMedix Group, Inc. Midland, TX 79701 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
1. Trade name: Verticor K-Wire System Common Name: K-wires Classification Name: Pin, Fixation Smooth/ Pin, Fixation, Threaded 21 CFR 888.3040 HTY/JDW Class ﺍﻟ

3. Predicate or legally marketed devices which are substantially equivalent:

KMedic External Fixation Devices (K030336 - Teleflex Medical Group) SMT Schilling Kirschner/Guide Wires (K100736 - SMT Schilling Metailtechnik GmbH)

4. Description of the device:

Materials:

316L stainless steel per ASTM F138

Function:

The K-wires are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction.

5. Substantial equivalence claimed to predicate devices

Verticor K-Wires are substantially equivalent to the KMedic External Fixation Devices and SMT Schilling Kirschner/Guide Wires in terms of intended use, design, and materials used. The table below compares the features and characteristics of the Verticor K-Wires to these predicate devices.

DeviceNameItems	Verticor K-WireSystem	KMedic ExternalFixation Devices	SMT SchillingKirschner/GuideWires
Sponsor	Verticor, LTD	Teleflex MedicalGroup	SMT SchillingMetailtechnik GmbH
510(k) Number	--	K030336	K100736
Device ClassificationName	Pin, FixationSmooth/Pin,	Pin, FixationSmooth/ Pin,	Pin, FixationSmooth/Pin,

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ItemsDevice Name	Verticor K-WireSystem	KMedic ExternalFixation Devices	SMT SchillingKirschner/GuideWires
	Fixation, Threaded	Fixation, Threaded	Fixation, Threaded
Product Code	HTY/JDW	HTY/JDW	HTY/JDW
Regulation #	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040
Classification	Class II	Class II	Class II
Indications for Use	See below	See 510(k) Summary	See 510(k) Summary
Material	316L stainless steel	316L stainless steel	316L stainless steel
Length	150 up to 450mm	102 up to 305mm	60 up to 500mm
Diameter	0.7 up to 1.6mm	0.7 up to 1.6mm	0.6 up to 6.35mm
Surface	Complete or partialsmooth and/orthreaded	Complete smooth orfully threaded	Complete or partialsmooth and/orthreaded, with orwithout threadingcutter
Tip geometry	•diamond or trocarpoint•round•flatwith or withoutspherical shape	•Double or single endtrocar point•Double or single enddiamond point	•diamond or trocarpoint•round•flat•with or without 3-or 4- shank ends•with or withoutspherical shape
Sterility	Non-sterile,sterilized in hospital	Non-sterile,sterilized in hospital	Non-sterile,sterilized in hospital

6. Intended Use:

7. Clinical Test Summary

No clinical studies were performed.

8. Conclusions Nonclinical and Clinical

Verticor K-Wire System is substantially equivalent to the predicate devices in terms of indications for use, ン design, material, and function.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Verticor, LTD % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

FEB 2 8 2511

Re: K110047

Trade/Device Name: Verticor K-Wire System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, JDW Dated: December 31, 2010 Received: January 6, 2011

Dear Mr. Webb.

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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federallions, or to 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, isting 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 micleading.

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, FTDA 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

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Page 2 – Mr. J.D. Webb

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-100, If you desire specific advice for your device on our labeling regulation (21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR P go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/15809.html
the Center for Devices and Radiological Hoolth on Offices/ucm/15809.htm for the Center for Devices and Radiological Health's (CDRH) S) Office of Compliance. 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 Biometil of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International on Consumer Assistance at its toll the manager (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

image://MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A.S. B. R.h
for

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: __ Verticor K-Wire System

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

form Melherm

S
(Division/Sign-Off)
Division of Surgical. Ofthopedic,
and Restorative Devices

510(k) Number K110047

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.