(48 days)
Not Found
No
The summary describes a mechanical device (pins and screws) for fracture fixation and makes no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as Pins intended for immobilization of fractures, which falls under the category of therapeutic devices for treating medical conditions.
No
The device description clearly states its purpose is for "immobilization of open and/or unstable fractures" by being "inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame". This describes a therapeutic device used to stabilize fractures, not to diagnose a condition.
No
The device description clearly states that the device is a physical Pin Screw manufactured from surgical grade stainless steel, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Pin Screw" intended for "immobilization of open and/of unstable fractures" by being "inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame."
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples from the patient. Its function is purely mechanical and structural, applied directly to the bone.
Therefore, this device falls under the category of a surgical implant or external fixation component, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
Product codes
JDW
Device Description
The Pin Screws have a tapered thread diameter and are available in a variety of diameter and lengths in both cortical and cancellous thread patterns. The Pin Screws will be available with and without the additional proprietary self-drilling on the threads.
The Pin Screws are manufactured from surgical grade stainless steel, 316L per BK MEDITECH CO.,LTD. ASTM F138. The Pin Screws are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures. The Pin Screws are provided non-sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone nearest the fracture site
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)
Reference Device(s)
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
K061599 (pg 1 of 2
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information
| Sponsor: | BK MEDITECH Co., Ltd.
215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si,
Kyunggi-Do, Republic of Korea |
|-------------------------|------------------------------------------------------------------------------------------------------|
| Manufacturing Site | BK MEDITECH Co., Ltd.
215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si,
Kyunggi-Do, Republic of Korea |
| US Agent: | Henry Yang
25041, Farrier Circle, Laguna Hills, CA 92653 |
| Official Correspondent: | Byungjun Park
215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si,
Kyunggi-Do, Republic of Korea |
Device Identification
| Proprietary Name: | Pin Screw |
|---|---|
| Common/Usual Name: | Fixation Pin |
| Classification Name: | Smooth or threaded metallic bone fixation fastener per 21 |
| CFR § 888.3040 | |
| Product Code: | JDW |
Substantially Equivalent Predicate Legally Marketed Devices
The subject device, Pin Screw, is substantially equivalent in function, design, composition, material and intended used to: Apex Fixation Pins(K011136)
Device Description
The Pin Screws have a tapered thread diameter and are available in a variety of diameter and lengths in both cortical and cancellous thread patterns. The Pin Screws will be available with and without the additional proprietary self-drilling on the threads.
The Pin Screws are manufactured from surgical grade stainless steel, 316L per BK MEDITECH CO.,LTD.
1
K061599 (pg 2 of 2)
ASTM F138.
The Pin Screws are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures
The Pin Screws are provided non-sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document.
Indications for Use
The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
Comparison to Legally Marketed Predicate Device
ﺮﻳﻌﻪ
The technological characteristics are the same as or equivalent to the predicate device previously listed.
Therewith, the Pin Screw is manufactured from 316L stainless steel which is identical to all of the identified predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or extensions reaching upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
BK Meditech Co., Ltd. % Mr. Byungjun Park Manager 215-5 Yodang-Li, Yanggam-Myun Hwasung-si, Kyunggi-do 445-931 Republic of Korea
Re: K061599
Trade/Device Name: Pin Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: June 5, 2006 Received: June 9, 2006
Dear Mr. Park:
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 complics 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
3
Page 2 - Mr. Byungjun Park
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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Barbara Buell
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO6 1599
Device Name:
Pin Screw
Indications for Use:
The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Aertina, Brechus in myen
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
510(k) NumberK MEDITECH CO.,LTD.
Pin Screw