(111 days)
No
The summary describes a system of screws and instruments for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the fixation of bone fractures and arthrodeses, which are therapeutic interventions.
No
The device description indicates that the Foot and Hand Motion is a system of screws and instruments for the fixation of bone fractures and arthrodeses, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it consists of screws and instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures and arthrodeses of the foot and hand. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of screws and instruments used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
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.
Product codes
HWC
Device Description
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).
Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3).
Function: The implants of Foot and Hand Motion are indicated for the fixation of bone fractures, for arthrodeses and for osteotomies of foot and hand in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and hand
Indicated Patient Age Range
adults
Intended User / Care Setting
health care professionals
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
No clinical studies were performed.
Non-clinical tests conducted:
- Comparative pullout tests.
- Torsional tests.
- Driving torque tests.
- Engineering analyses.
- Endotoxins testing is performed using LAL quantitative kinetic chromogenic method.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
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
1
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
2
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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)
-
- 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 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). |
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM
F 136 and/or ISO 5832-3). |
| Function: | The implants of Foot and Hand Motion are
indicated for the fixation of bone fractures,
for arthrodeses and for osteotomies of foot
and 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.