(49 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation, with no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is intended for "arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot," which are medical conditions that the device is designed to treat or alleviate.
No
The device is described as an implantable system of plates and screws intended for fixation and revision surgeries of the foot, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it consists of "plates and screws," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." This describes a surgical procedure involving the fixation of bone, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device consists of "plates and screws." These are physical implants used in surgery, not reagents, instruments, or software used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or analytical methods
The device is clearly a surgical implant system used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The implants of the Footmotion Plating System are 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.
Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI (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.
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
Not Found
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)
Non-clinical tests were conducted:
- 4-point-bending tests per ASTM F382 were conducted to compare the bending strength of the subject device plates to the predicates.
- ASTM F543 torsional testing was performed on the subject screws. Equation described by Chapman for axial pull-out strength was performed on the subject screws (FDA-Guidance: Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020).
- Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Footmotion Plating System is substantially equivalent to cleared predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K161448 / K171510, K121651, K061808, K132898, K190365
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
July 1, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K221395
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: May 11, 2022 Received: May 13, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6A: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221395
Device Name Footmotion Plating System
Indications for Use (Describe)
The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision 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)
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Image /page/3/Picture/0 description: The image shows the logo for New Clip-Technics. The logo features the letters "nct" in a stylized, lowercase font, with a red arrow pointing upwards replacing the top of the "t". The letters are enclosed in a black circle. Below the circle, the words "NEW CLIP-TECHNICS" are written in a bold, sans-serif font, with a hyphen separating "CLIP" and "TECHNICS".
K221395 Page 1 of 4
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: April 29, 2022
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. 4313 W. 3800 S. West Haven. UT 84401 Telephone: 512-590-5810
| 2. Trade name: | Footmotion Plating System |
|---|---|
| Common Name: | Plate, Fixation, Bone / Screw, Fixation, bone |
| 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 shows the logo for New Clip-Technics. The logo features the letters "nct" in a stylized, lowercase font, with the "t" having an upward-pointing arrow as its vertical component. The letters are enclosed within a black circle. Below the circle, the words "NEW CLIP-TECHNICS" are written in a sans-serif font, with a hyphen separating "CLIP" and "TECHNICS".
3. Primary predicate or legally marketed devices which are substantially equivalent:
Additional predicate or legally marketed devices which are substantially equivalent:
- Ortholoc® 3Di Midfoot/Flatfoot System of Wright Medical Technology ● (K121651).
- DARCO Locking Bone Plate System of Wright Medical Technology ● (K061808),
- A.L.P.S Calcaneal Plating System of Biomet (K132898),
- Gorilla® Plating System of Paragon28 (K190365), ●
- ActivAnkle (K143061/K173641) of Newclip Technics. ●
-
- 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.
- CP Titanium (conform to ASTM F67 and ISO Materials: 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).
- The implants of the Footmotion Plating System Function: are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
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K221395 Page 3 of 4
Image /page/5/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 a red arrow pointing upwards. Below the circle, the words "NEWCLIP-TECHNICS" are written in all caps.
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 performance.
6. Intended use:
The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
7. Summary of the technological characteristics compared to predicate
Intended Use
The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
Indications for Use
All of the devices comply with the indications for use specified in 21 CFR section 888.3030 for metallic bone fixation devices.
Material
The Footmotion Plating System uses the same material as the predicate devices.
Design
The Footmotion Plating System and the predicates are equivalent in terms of shape, material, and operating principles.
Sizes
The Footmotion Plating System and the predicates are equivalent in their dimensions.
8. Non-clinical Test Summary:
The following tests were conducted:
-
4-point-bending tests per ASTM F382 were conducted to compare the bending strength of the subiect device plates to the predicates.
-
ASTM F543 torsional testing was performed on the subject screws. Equation described by Chapman for axial pull-out strength was performed on the subject screws (FDA-Guidance: Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020).
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Image /page/6/Picture/0 description: The image shows a logo for "NEWCLIP-TECHNICS". The logo consists of a circle containing the letters "nc" in a stylized font, 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, with hyphens separating the words.
- Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Footmotion Plating System is substantially equivalent to cleared predicates.
9. Clinical Test Summary:
No clinical studies were performed.
10. Conclusions Non-clinical and clinical:
Based on the indications for use, technological characteristics, and the summary of data submitted, Newclip Technics determined that the Footmotion Plating System is substantially equivalent to the cleared predicate devices listed above.