(159 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a bone plating system, with no mention of AI or ML.
No
The device is intended for fixation during fracture and osteotomy surgeries, which is a supportive role in a surgical procedure, not a therapeutic treatment of a condition itself.
No
Explanation: The device is a plating system intended for fixation surgeries of the foot, not for diagnosing medical conditions. It is used in treatment, not diagnosis.
No
The device description explicitly states it consists of physical components (plates and screws made of titanium alloy) and undergoes physical performance testing (fatigue, static, torsional tests), indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthrodeses, fractures and osteotomies fixation surgeries of the foot in adults." This describes a surgical implant used in vivo (within the body) to fix bones.
- Device Description: The description details a "plate with as many screws as holes (slots)" made of titanium alloy. This is consistent with a surgical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The Footmotion Plating System is a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation surgeries of the foot in adults.
Product codes
HRS, HWC
Device Description
The Footmotion Plating System consists of a plate with as many screws as holes (slots) designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The plates and screws are manufactured from titanium alloy and color anodized.
The Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or 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
Non-clinical Test Summary:
The following tests were conducted:
- Comparative fatigue compression tests. (ASTM F382) .
- Comparative static tests. (ASTM F382) .
- Torsional tests. (ASTM F543) .
- Engineering analysis. .
- Endotoxin testing is performed using the LAL quantitative kinetic . chromogenic method. Testing is performed on worst case representatives from the company's products. The testing demonstrated that the subject devices meet the recommended maximum endotoxin level of 20 EU per device.
- . Since water used in the cleaning steps is a possible source of endotoxin, testing is performed on the water and includes bioburden, TOC, THC, and LAL. The maximum limit for endotoxin level is established at 0.25 EU/mL and has never been reached.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be emerging from a single base. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
The Orthomedix Group, Inc. % J.D. Webb Official Correspondent 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K161448
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: September 16, 2016 Received: September 20, 2016
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 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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Page 2 - J.D. Webb
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 yours,
Lori A. Wiggins -S
for 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 surgeries of the foot in adults.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters "nct" inside of a circle. The "t" in "nct" is red and has an arrow pointing upwards. Below the circle, the words "NEWCLIP-TECHNICS" are written in all caps.
510 (k) Summary for the Footmotion Plating System
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: October 18, 2016
| 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 |
| 2. Trade name: | Footmotion Plating System |
| Common Name: | Plates for foot 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) |
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Image /page/4/Picture/1 description: The image is a logo for NEWCLIP-TECHNICS. The logo features the letters "nct" inside of a circle. The "t" in "nct" has been stylized to look like an upward-pointing arrow and is a different color than the other letters.
3. Primary predicate or legally marketed devices which are substantially equivalent:
- The Anchorage® Bone Plate System of Memometal (K083447), .
Secondary predicate or legally marketed devices which are 4. substantially equivalent:
- The Ortholoc® 3Di Midfoot/Flatfoot System of Wright Medical . Technology (K121651),
- The Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256). .
| 5. | Description of the device: | The Footmotion Plating System consists of a plate with as many screws as holes (slots) designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The plates and screws are manufactured from titanium alloy and color anodized. |
|---|---|---|
| The Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. | ||
| Materials: | Titanium alloy Ti-6Al-4V ELI (conforms to ASTM F 136-13 and/or ISO 5832-3). | |
| Function: | The implants of the Footmotion Plating System are indicated for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. |
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Image /page/5/Picture/1 description: The image shows the logo for 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. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font. The logo is simple and modern.
6. Substantial equivalence claimed to predicate devices:
The Footmotion Plating System is substantially equivalent to the Anchorage® Plate System of Memometal (K083447), the Ortholoc® 3Di Bone Midfoot/Flatfoot System of Wright Medical Technology (K121651) and the Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256) in terms of intended use, design, materials used, mechanical safety and performance.
7. Intended use:
The Footmotion Plating System is indicated for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
Non-clinical Test Summary: 8.
The following tests were conducted:
- Comparative fatigue compression tests. (ASTM F382) .
- Comparative static tests. (ASTM F382) .
- Torsional tests. (ASTM F543) .
- Engineering analysis. .
- Endotoxin testing is performed using the LAL quantitative kinetic . chromogenic method. Testing is performed on worst case representatives from the company's products. The testing demonstrated that the subject devices meet the recommended maximum endotoxin level of 20 EU per device.
- . Since water used in the cleaning steps is a possible source of endotoxin, testing is performed on the water and includes bioburden, TOC, THC, and LAL. The maximum limit for endotoxin level is established at 0.25 EU/mL and has never been reached.
9. Clinical Test Summary:
No clinical studies were performed.
10. Conclusions Non-clinical and Clinical:
The Footmotion Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.