(34 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or any data-driven analysis.
No
The device is described as a K-Wire, used for fixation of bone fractures and as guide pins, which is a structural or surgical aid, not a device that directly treats a condition or disease in a therapeutic manner.
No
Explanation: The Intended Use/Indications for Use section describes the Arthrex K-Wire as a device for fixation, reconstruction, and guidance related to bone fractures and skeletal systems. It does not mention any function for diagnosing conditions.
No
The device description explicitly states the device is made of stainless steel and is offered in several sizes and tip styles, indicating it is a physical hardware device.
Based on the provided information, the Arthrex K-Wire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function in the fixation and manipulation of bone within the body. This is an in vivo application (within a living organism).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The Arthrex K-Wire does not perform this function.
- Device Description: The description focuses on the material and physical characteristics of a surgical implant.
- Lack of IVD-related information: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical elements associated with IVD devices.
Therefore, the Arthrex K-Wire is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Examples include:
- Fixation of small bone fragments, in long bone or small bone fractures .
- Arthrodesis in hand and foot surgery .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Mono or Bi-Cortical osteotomies in the foot or hand .
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
- . Guide Wire in hip pinning procedures
- Align and reduce long bone fractures .
- For use with cerclage wire/cable in treating greater trochanter fractures ●
Product codes
HTY
Device Description
The Arthrex K-Wire devices are made of stainless steel per ASTM F138. They are offered in several sizes and tip styles, sterile or non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, hand, foot, hip
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV - 3 2005
510(k) Summary
K 052736
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse, RAC |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A milano, 1/ 3Allino |
| Trade Name: | Arthrex K-Wire |
|---|---|
| Common Name: | Pin |
| Classification: | Smooth or threaded metallic bone fixation fastener |
| Product Code: | HTY |
Description:
The Arthrex K-Wire devices are made of stainless steel per ASTM F138. They are offered in several sizes and tip styles, sterile or non-sterile.
Indications for Use:
The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as quide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Examples include:
- Fixation of small bone fragments, in long bone or small bone fractures .
- Arthrodesis in hand and foot surgery .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Mono or Bi-Cortical osteotomies in the foot or hand .
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
- Guide Wire in hip pinning procedures .
- Align and reduce long bone fractures .
- For use with cerclage wire/cable in treating greater trochanter fractures ●
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications for use. These indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials used in construction of these devices are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2005
Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex. Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K052736
Trade/Device Name: Arthrex K-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fastener Regulatory Class: II Product Code: HTY Dated: September 29, 2005 Received: September 30, 2005
Dear Ms. Waterhouse:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Ann Waterhouse, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Examples include:
- Fixation of small bone fragments, in long bone or small bone fractures .
- Arthrodesis in hand and foot surgery .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Mono or Bi-Cortical osteotomies in the foot or hand .
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
- . Guide Wire in hip pinning procedures
- Align and reduce long bone fractures .
- For use with cerclage wire/cable in treating greater trochanter fractures ●
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Numbor K052736