(49 days)
The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
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.
This FDA 510(k) summary is for a medical device called the Footmotion Plating System, which is a metallic bone fixation device. As such, the "acceptance criteria" and "device performance" are typically related to mechanical and material properties rather than diagnostic accuracy or clinical outcomes. The study described is a non-clinical, benchtop study.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | 4-point-bending (plates) | Performance comparable to predicates (ASTM F382 standards) | Subject device plates performance found to be comparable to predicates. |
| Mechanical Performance | Torsional testing (screws) | Performance aligned with predicate standards (ASTM F543) | Performed on subject screws (details not quantified but implies acceptable performance vs. predicates). |
| Mechanical Performance | Axial pull-out strength (screws) | Performance aligned with predicate standards (Equation described by Chapman, FDA-Guidance: Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020) | Performed on subject screws (details not quantified but implies acceptable performance vs. predicates). |
| Biocompatibility | Endotoxin testing | Acceptable endotoxin levels (LAL quantitative kinetic chromogenic method) | Testing performed and results considered acceptable. |
| Material Equivalence | Material Composition | Conform to predicate materials (CP Titanium per ASTM F67/ISO 5832-2; Titanium alloy Ti-6Al-4V ELI per ASTM F136/ISO 5832-3) | Uses the same materials as the predicate devices. |
| Design Equivalence | Shape, Material, Operating Principles | Equivalent to predicate devices | Equivalent in terms of shape, material, and operating principles. |
| Dimensional Equivalence | Sizes | Equivalent to predicate devices | Equivalent in their dimensions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of plates or screws tested. However, mechanical testing typically involves a sufficient number of samples to achieve statistical significance.
- Data Provenance: The studies are non-clinical (benchtop) tests performed by the manufacturer, Newclip Technics, as part of their 510(k) submission. There is no mention of country of origin for the data or if it's retrospective/prospective as these terms are not applicable to non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For mechanical and material testing of this nature, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO, FDA guidance documents) and the results of the physical tests themselves. Human experts are involved in designing and conducting the tests, interpreting the raw data, and comparing it to the performance of predicate devices, but they are not establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human assessment of clinical data, especially in diagnostic accuracy claims. For benchtop mechanical testing, the results are typically quantitative and objective, directly compared against established standards or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- Not Applicable. This device is a bone fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and the concept of "human readers improving with AI vs. without AI assistance" are not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This device is a physical medical implant (plating system), not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical performance of the device is established by:
- Adherence to recognized industry standards: ASTM F382 (for plate bending), ASTM F543 (for screw torsion), and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020" (for screw axial pull-out).
- Comparison to predicate devices: The subject device's mechanical and material properties are demonstrated to be "substantially equivalent" to legally marketed predicate devices.
- Biocompatibility testing: Endotoxin levels assessed by LAL quantitative kinetic chromogenic method.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device because it is a physical hardware device, not a machine learning or AI algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
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July 1, 2022
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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
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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
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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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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, BoneHWC - Screw, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixationappliances and accessories. (21 CFR part. 888.3030)Smooth or threaded metallic bone fixation fastener.(21CFR 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
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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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- 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.
§ 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.