The Foot and Hand Motion consists of screws designed for the fixation of bone fractures, for arthrodeses and for osteotomies of foot and hand in adults. The implants of the Foot and Hand Motion will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Foot and Hand Motion will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization (Initial S single use kits).

AI/ML Overview

This document is a 510(k) summary for a medical device called "Foot and Hand Motion" by NEWCLIP TECHNICS. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics. Therefore, many of the requested elements for describing acceptance criteria and a study are not directly available in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in a quantitative format within the document. The document primarily focuses on establishing substantial equivalence through non-clinical testing and similarity to predicate devices. There are no explicit performance acceptance criteria (e.g., minimum pullout strength in Newtons) or reported device performance values in a table.

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

Sample Size for Test Set: Not specified in terms of number of screws tested. The non-clinical tests mention "Comparative pullout tests," "Torsional tests," and "Driving torque tests," but the number of samples used for these tests is not quantified.
Data Provenance: The tests are non-clinical (laboratory tests). There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The tests mentioned are non-clinical engineering and material tests (e.g., pullout, torsional strength), not diagnostic or clinical studies that would require expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable, as there is no human-involved "test set" requiring adjudication in the context of this 510(k) summary.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, an MRMC study was not conducted.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The device is a physical bone fixation system (screws), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable. For the non-clinical tests mentioned, the "ground truth" would be established by the testing protocols and measurements of physical properties (e.g., force, torque) of the device.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. There is no training set mentioned.

Summary of Available Information from the Document:

The document establishes that the "Foot and Hand Motion" device is substantially equivalent to predicate devices based on:

Intended Use: Fixation of bone fractures and arthrodeses of the foot and hand in adults.
Design, Materials, Mechanical Safety, and Performance.
Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3).
Non-Clinical Tests Conducted:
- Comparative pullout tests
- Torsional tests
- Driving torque tests
- Engineering analyses
- Endotoxins testing using LAL quantitative kinetic chromogenic method.
Clinical Studies: None were performed.

The conclusion is that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use with the listed predicate devices. The "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence through these non-clinical tests and comparison to the predicate devices, rather than explicit numerical performance targets.

Summary

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2017

NEWCLIP TECHNICS % Mr. J.D. Webb Official Correspondent The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock. Texas 78681

Re: K170012

Trade/Device Name: Foot and Hand Motion Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 5, 2017 Received: April 6, 2017

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 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K170012

Device Name Foot and Hand Motion

Indications for Use (Describe)

The implants of the Foot and Hand Motion are intended for the fixation of bone fractures and for arthrodeses of the foot and hand in adults.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows a logo for "NEWCLIP-TECHNICS". The logo features the letters "nct" inside of a circle. The "t" in "nct" is colored in a shade of pink. The text "NEWCLIP-TECHNICS" is written in all caps below the circle.

510 (k) Summary for the FOOT AND HAND MOTION 4.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) Summary is submitted for the Foot and Hand Motion.

Summary preparation date: April 14, 2017

1. Submitter:

Contact Person:

NEWCLIP TECHNICS	J.D. Webb
P.A. de la Lande Saint Martin	The OrthoMedix Group, Inc.
45 rue des Garottières	1001 Oakwood Blvd
F-44115 Haute-Goulaine - France	Round Rock, TX 78681
Telephone: (33) 2 28 21 37 12	Telephone: 512-388-0199

Foot and Hand Motion 2. Trade name: Fracture fixation screws Common Name: Product code: HWC Classification Name: Screw, Fixation, Bone (21 CFR part. 888.3040)
1. Primary predicate or legally marketed devices which are substantially equivalent:
- . FHM System of Newclip Technics (K091118)

Secondary predicate or legally marketed devices which are substantially equivalent:

SBI Autofix System of Small Bone Innovations (K052576) .
TwistCut-Snap Off Bone screws of MERETE (K051323) o
. Large Screws Range of Newclip Technics (K160617)
. Footmotion Plating System of Newclip Technics (K161448)

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Image /page/4/Picture/1 description: The image shows the logo for Newclip Technics. The logo consists of the letters "nct" inside of a circle. The "t" in "nct" has an upward-pointing arrow as part of the letter and is colored in pink. Below the circle, the words "NEWCLIP-TECHNICS" are written in all caps.

4. Description of the device:	The Foot and Hand Motion consists ofscrews designed for the fixation of bonefractures, for arthrodeses and forosteotomies of foot and hand in adults.
	The implants of the Foot and Hand Motionwill be provided non sterile for sterilizationby health care professionals prior to use orprovided sterile by gamma sterilization.The instruments of the Foot and HandMotion will be provided non sterile forsterilization by health care professionalsprior to use or provided sterile by gammasterilization (Initial S single use kits).
Materials:	Titanium alloy Ti-6Al-4V (conform to ASTMF 136 and/or ISO 5832-3).
Function:	The implants of Foot and Hand Motion areindicated for the fixation of bone fractures,for arthrodeses and for osteotomies of footand hand in adults.

5. Substantial equivalence claimed to predicate devices:

The Foot and Hand Motion is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

6. Indications for Use:

The implants of the Foot and Hand Motion are intended for the fixation of bone fractures and osteotomies, and for arthrodeses of the foot and hand in adults.

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Image /page/5/Picture/1 description: The image shows a logo for a company called NEWCLIP-TECHNICS. The logo consists of a circle with the letters "nct" inside. The "t" has an upward-pointing arrow as part of the letter. The company name is written in all caps below the circle.

7. Non-clinical Test Summary:

The following tests were conducted:

Comparative pullout tests. .
Torsional tests. .
Driving torque tests. .
Engineering analyses .
Endotoxins testing is performed using LAL quantitative kinetic chromogenic . method.

8. Clinical Test Summary:

No clinical studies were performed.

9. Conclusions Non-clinical and Clinical:

Newclip considers the Foot and Hand Motion to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.

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.