MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL by MEDICAL FACETS

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

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.

AI/ML Overview

The provided text describes the acceptance criteria and a study for Medical Facets Bone Fixation Screws and Pins.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Standards)	Reported Device Performance
ASTM F543 (Metallic Medical Bone Screws)	Substantial performance of the worse case in side-by-side testing with the predicate device.
ASTM F2193 (Components Used in the Surgical Fixation of the Spinal Skeletal System)	Substantial performance of the worse case in side-by-side testing with the predicate device.
ASTM F1264 (Intramedullary Fixation Devices)	Substantial performance of the worse case in side-by-side testing with the predicate device.
ASTM F1541 (External Skeletal Fixation Devices)	Substantial performance of the worse case in side-by-side testing with the predicate device.

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

The document does not specify a distinct "test set" in the context of clinical trials or AI/algorithm performance. Instead, it refers to "Non-Clinical Testing (worse case)" where the device was mechanically tested according to the listed ASTM standards. The specific sample size for these mechanical tests is not provided, nor is the data provenance in terms of country of origin or retrospective/prospective nature, as these are typically associated with clinical studies involving human or animal subjects, which is not the type of study described here.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is a mechanical testing study, not a study involving expert assessment of images or clinical outcomes to establish a ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This is a mechanical testing study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not done. The study described is a non-clinical mechanical testing comparison between the subject device and predicate devices. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance:

No. This is a medical device, specifically bone fixation screws and pins, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

The "ground truth" in this context is defined by the mechanical performance requirements specified in the ASTM standards (F543, F2193, F1264, F1541). The device's performance was compared to the performance of "predicate devices" during "side-by-side testing," implicitly meaning it met or exceeded the established mechanical properties and stability criteria for similar devices on the market.

8. Sample Size for the Training Set:

Not applicable. This is a mechanical testing study of a physical device, not an AI or algorithm that requires a training set.

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

Not applicable. No training set was used.

Summary

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长川2727 (113)

JAN 1 3 2012

6. 510(k) Summary

Manufacturer:	Medical Facets NC LLC1669 Federal Ave.Gastonia, NC 28052
Date:	September 15, 2011
Submitted by:	Medical Facets NC LLC
Company Contact	Glenn A. Rupp, President1669 Federal Ave.Gastonia, NC 28052(704) 562-7494(704) 853-2105 (FAX)
US Agent Information	Orgenix LLCMr. Donald W. Guthner111 Hill RoadDouglassville, 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 ScrewsMedical Facets Cancellous ScrewsMedical Facets Headless Compression ScrewsMedical Facets External Fixation ScrewsMedical Facets Pins and Guide Wires
Performance standards:	The Medical Facets Cortical Screws, Medical Facets CancellousScrews. Medical Facets Headless Compression Screws, MedicalFacets External Fixation Screws, and Medical Facets Pins andGuide Wires were mechanically tested to the following standards -ASTM F543, ASTM 1264, ASTM F2193 and ASTM F1541(current versions).
Classification no .:	21CFR 888.3040HWC, JDW, HTYClass II87/Orthopedic Panel

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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

Intended Use:

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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.

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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

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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

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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

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

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.