(115 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and testing of bone fixation hardware, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as "fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices," which are structural components rather than devices that directly provide therapeutic effects through energy, substance, or other active means.
No
The device is described as fixation implants for bone fractures, joint fusion, and bone reconstruction, or as guide pins for other implantable devices, which are therapeutic and procedural uses, not diagnostic.
No
The device description clearly outlines physical hardware components (screws, pins, wires) made of materials like stainless steel and titanium, with specific dimensions and features. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly states that the Medical Facet Bone Fixation Screws and Pins are implantable devices used for fixing bone fractures, joint fusion, bone reconstruction, or as guide pins during surgery. They are physically inserted into the body to provide structural support.
This function is entirely different from the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.
Product codes
HWC, JDW, HTY
Device Description
Medical Facets Bone Screws are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.
Medical Facets External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.
Medical Facets Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm. 0.028 inches to 0.062 inches, in lengths ranging from 4.0 inches to 12.0 inches and are partially or completely threaded. or smooth. Made of stainless steel or titanium.
Medical Facets Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.
Medical Facets Steinmann Pins are available in wire diameters ranging from 0.078 inches to 0.187 inches, in lengths ranging from 9.0 inches to 12.0 inches, are completely threaded, or smooth. Made of stainless steel or titanium.
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
The Medical Facet Bone Fixation Screws and Pins were mechanically tested to the following standards: ASTM F543, ASTM 1264, ASTM F2193 and ASTM F1541 (current versions). Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device. The information discussed above demonstrates that the Medical Facet Bone Fixation Screws and Pins are effective and perform as well as or better than the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K083912, K090047, K911505, K051605
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
长川2727 (113)
JAN 1 3 2012
6. 510(k) Summary
| Manufacturer: | Medical Facets NC LLC
1669 Federal Ave.
Gastonia, NC 28052 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 15, 2011 |
| Submitted by: | Medical Facets NC LLC |
| Company Contact | Glenn A. Rupp, President
1669 Federal Ave.
Gastonia, NC 28052
(704) 562-7494
(704) 853-2105 (FAX) |
| US Agent Information | Orgenix LLC
Mr. Donald W. Guthner
111 Hill Road
Douglassville, PA 19518
+1-646-460-2984
+1-484-363-5879 (FAX) |
| Classification Name: | Screw, Fixation Bone; Pin, Fixation Smooth or Threaded |
| Common/Usual Name: | Bone Fixation Screws and Pins |
| Proprietary Name: | Medical Facets Cortical Screws
Medical Facets Cancellous Screws
Medical Facets Headless Compression Screws
Medical Facets External Fixation Screws
Medical Facets Pins and Guide Wires |
| Performance standards: | The Medical Facets Cortical Screws, Medical Facets Cancellous
Screws. Medical Facets Headless Compression Screws, Medical
Facets External Fixation Screws, and Medical Facets Pins and
Guide Wires were mechanically tested to the following standards -
ASTM F543, ASTM 1264, ASTM F2193 and ASTM F1541
(current versions). |
| Classification no .: | 21CFR 888.3040
HWC, JDW, HTY
Class II
87/Orthopedic Panel |
1
Substantial equivalence for Medical Facets Cortical Screws, Substantial Equivalence: Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical Facets External Fixation Screws, and Medical Facets Pins and Guide Wires is based on the similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions:
- K083912 Treu Instrumente GmBH Bone Fixation Screws and . Pins
- . K090047 Synthes 1.5 Mini Fragment LCP System
- K911505 Simpex, Inc. Fixation Wire .
- K051605 SBI K-wires .
cleared devices.
Predicate Devices:
Device Description:
Medical Facets Bone Screws are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.
The subject device is substantially equivalent to similar previously
Medical Facets External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.
Medical Facets Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm. 0.028 inches to 0.062 inches, in lengths ranging from 4.0 inches to 12.0 inches and are partially or completely threaded. or smooth. Made of stainless steel or titanium.
Medical Facets Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.
Medical Facets Steinmann Pins are available in wire diameters ranging from 0.078 inches to 0.187 inches, in lengths ranging from 9.0 inches to 12.0 inches, are completely threaded, or smooth. Made of stainless steel or titanium.
Intended Use:
The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.
2
Summary of The Medical Facet Bone Fixation Screws and Pins are Technological manufactured in Stainless Steel, Titanium and Cobalt (guide wires Characteristics only). The Medical Facet Bone Fixation Screws and Pins were tested Non-Clinical Testing (worse case) according to the following standards: ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F2193 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices ASTM F1541 - Standard Specification and Test Methods for External Skeletal Fixation Devices Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device. Conclusion The information discussed above demonstrates that the Medical Facet Bone Fixation Screws and Pins are effective and perform as well as or better than the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medical Facets NC LLC % Mr. Glenn A. Rupp President 1669 Federal Avenue Gastonia, North Carolina 28052
JAN 1 3 2012
Re: K112727
Trade/Device Name: Medical Facets Cortical Screws Medical Facets Cancellous Screws Medical Facets Headless Compression Screws Medical Facets External Fixation Screws Medical Facets Pins and Guide Wires
Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastner Regulatory Class: II Product Code: HWC, JDW, HTY Dated: December 15, 2011 Received: December 16, 2011
Dear Mr. Rupp:
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
4
Page 2 - Mr. Glenn A. Rupp
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to 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 Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
5. Indications for Use
510(k) Number (if known):
Medical Facets Cortical Screws Device Name: Medical Facets Cancellous Screws Medical Facets Headless Compression Screws Medical Facets External Fixation Screws Medical Facets Pins and Guide Wires
The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices
2 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)
Concurrenee of CDRH, Office of Device Evaluation (ODE)
for (Division Sign-Off)
sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112727
ATT. 1-21