(107 days)
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI/ML, image processing, or data sets for training/testing.
No
Explanation: This device is intended for fracture fixation and revision surgeries, which are corrective and restorative procedures. Therapeutic devices typically involve treating or curing a disease or condition, or alleviating symptoms, which is not the primary function described for this plate and screw system.
No
The device description and intended use clearly state that the Footmotion Plating System is for "fixation and revision surgeries of the foot" (e.g., for fractures, osteotomies). This indicates a therapeutic or reconstructive purpose, not a diagnostic one. Diagnostic devices are used to identify or determine the presence of a disease or condition.
No
The device description explicitly states it consists of "plates and screws," which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "plates and screws" which are implants used to fix bones. This is a surgical implant, not a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (like blood, urine, tissue) or providing information about a patient's health status based on such analysis. IVDs are designed to perform these types of diagnostic tests.
The Footmotion Plating System is a surgical device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial F MTP) contain implants and instruments or instruments only provided sterile by gamma sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analyses have been conducted in comparison with the predicate devices.
LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K171510
Trade/Device Name: Footmotion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 10, 2017 Received: August 14, 2017
Dear J.D. 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
1
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 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Footmotion Plating System
Indications for Use (Describe)
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K171510 Page 1 of 3
Image /page/3/Picture/1 description: The image is a logo for Newclip-Technics. The logo features the letters "nc" in a circle, with an arrow pointing upwards in the color red. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
510 (k) Summary for the FOOTMOTION PLATING SYSTEM 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Footmotion Plating System.
Summary preparation date: May 22, 2017
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICS | |
| P.A. de la Lande Saint Martin | |
| 45 rue des Garottières | |
| F-44115 Haute-Goulaine - France | |
| Telephone: (33) 2 28 21 37 12 | J.D. Webb |
| The OrthoMedix Group, Inc. | |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| Telephone: 512-388-0199 | |
| 2. Trade name: | Footmotion Plating System |
| Common Name: | Plates for fractures, osteotomies and |
| arthrodeses | |
| Screws associated | |
| Instrumentation associated | |
| Product code: | HRS - Plate, Fixation, Bone |
| HWC - Screw, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone |
| fixation appliances and accessories. | |
| (21 CFR part. 888.3030) | |
| Smooth or threaded metallic bone fixation | |
| fastener (21 CFR part. 888.3040) |
4
Image /page/4/Picture/1 description: The image shows the logo for Newclip-Technics. The logo features the letters "nc" in a circle, with a red arrow pointing upwards replacing the right side of the "t". Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
3. Primary predicate or legally marketed devices which are substantially equivalent:
- Footmotion Plating System of Newclip Technics (K161448) .
Secondary predicate or legally marketed devices which are substantially equivalent:
- Ortholoc 3Di Hallux System of Wright Medical Technology (K120359) .
Reference device:
- Alians Clavicle Range of Newclip Technics (K170310) .
| 4. Description of the device: | The Footmotion Plating System consists of
plates and screws, designed for
arthrodeses, fractures and osteotomies
fixation and revision surgeries of the foot in
adults. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The implants of the Footmotion Plating
System will be provided non sterile for
sterilization by health care professionals
prior to use or provided sterile by gamma
sterilization.
The instruments of the Footmotion Plating
System will be provided non sterile for
sterilization by health care professionals
prior to use.
Single use kits (Initial F MTP) contain
implants and instruments or instruments
only provided sterile by gamma
sterilization. |
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM
F136 and ISO 5832-3). |
| Function: | The implants of the Footmotion Plating
System are intended for arthrodeses,
fractures and osteotomies fixation and
revision surgeries of the foot in adults. |
5
Image /page/5/Picture/1 description: The image shows a logo for "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nc" inside, and a red arrow pointing upwards is placed above the "c". Below the circle, the words "NEWCLIP-TECHNICS" are written in a simple, sans-serif font. The logo has a clean and modern design.
5. Substantial equivalence claimed to predicate devices:
The Footmotion Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
6. Intended use:
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
7. Non-clinical Test Summary:
Engineering analyses have been conducted in comparison with the predicate devices.
LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of