(53 days)
Not Found
No
The summary describes a simple mechanical device (K-wires) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a K-Wire System used for fixation of bone fractures, fusion of joints, bone reconstruction, and as guide pins for other implants, which are mechanical interventions rather than therapeutic treatments.
No
The device is described as K-wires, which are pins used for fixation of bone fractures, fusion of joints, or bone reconstruction. Its function is to physically hold bone fragments together or guide the insertion of other implants, not to diagnose a condition.
No
The device description clearly states it is a physical device made of stainless steel pins (K-wires), not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Verticor K-Wire System function: The description clearly states that the Verticor K-Wire System is used for the fixation of bone fractures, fusion of joints, bone reconstruction, and as guide pins for implant insertion. These are all procedures performed directly on the body (in vivo) and involve physical manipulation of bone.
The device description and intended use are entirely focused on surgical procedures and mechanical support within the body, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
HTY, JDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
//0047
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
-
- 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
-
- 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:
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.
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.
| Device
Name
Items | Verticor K-Wire
System | KMedic External
Fixation Devices | SMT Schilling
Kirschner/Guide
Wires |
|-------------------------------|------------------------------|-------------------------------------|-------------------------------------------|
| Sponsor | Verticor, LTD | Teleflex Medical
Group | SMT Schilling
Metailtechnik GmbH |
| 510(k) Number | -- | K030336 | K100736 |
| Device Classification
Name | Pin, Fixation
Smooth/Pin, | Pin, Fixation
Smooth/ Pin, | Pin, Fixation
Smooth/Pin, |
1
| Items
Device Name | Verticor K-Wire
System | KMedic External
Fixation Devices | SMT Schilling
Kirschner/Guide
Wires |
|----------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | 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 partial
smooth and/or
threaded | Complete smooth or
fully threaded | Complete or partial
smooth and/or
threaded, with or
without threading
cutter |
| Tip geometry | •diamond or trocar
point
•round
•flat
with or without
spherical shape | •Double or single end
trocar point
•Double or single end
diamond point | •diamond or trocar
point
•round
•flat
•with or without 3-
or 4- shank ends
•with or without
spherical shape |
| Sterility | Non-sterile,
sterilized in hospital | Non-sterile,
sterilized in hospital | Non-sterile,
sterilized in hospital |
6. Intended Use:
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.
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.
2
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
3
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
4
Indications for Use
510(k) Number (if known):
Device Name: __ Verticor K-Wire System
Indications for Use:
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.
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