(118 days)
Not Found
No
The summary describes a traditional mechanical plating system and does not mention any AI/ML components or capabilities.
No.
The device is a plating system intended for trauma and reconstructive procedures of small bones, which is a structural implant and not a therapeutic device.
No
Explanation: The device is a plating system intended for trauma and reconstructive procedures of small bones, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like plates, screws, washers, and instruments, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device." This describes a surgical implant and associated instruments used directly on the patient's body.
- Device Description: The description details plates, screws, washers, and instruments made of titanium alloy for surgical procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The Arsenal Plating System is a surgical device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.
Product codes
HRS, HWC, NDG
Device Description
The Arsenal Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The system will incorporate multiple locking and non-locking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the hand/foot, ankle, and other bones appropriate for the device.
Indicated Patient Age Range
Not Found
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
Non-Clinical Test Summary:
Study type: Mechanical testing
Sample size: Not specified
Key results: The results of these evaluations indicate that the Arsenal Plating System is equivalent to the predicate devices.
Studies performed:
- Single Cycle Bend Testing referencing ASTM F382
- Dynamic Bend Testing referencing ASTM F382
- Axial Pullout Strength Testing referencing ASTM F543
- Torsional Property Testing referencing ASTM F543
- Driving Torque Testing referencing ASTM F543
Clinical Test Summary: No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K983495, K131445, K160177, K130964
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.
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August 12, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Trilliant Surgical Christopher Radzicki R&D Engineer 727 North Shepherd Drive, Suite 100 Houston, Texas 77007
Re: K191009
Trade/Device Name: Arsenal 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, NDG Dated: July 11, 2019 Received: July 11, 2019
Dear Christopher Radzicki:
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,
Shumaya Ali, MPH 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191009
Device Name Arsenal Plating System
Indications for Use (Describe)
The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.
| 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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510(k) Summary Arsenal Plating System
In accordance with 21 CFR 807.92(c) of the Federal Code of Regulations, the following 510(k) summary is submitted for the Arsenal Plating System.
l. GENERAL INFORMATION
| Date Prepared | April 15th, 2019 |
|---|---|
| Submitted By | Trilliant Surgical |
| 727 North Shepherd Drive | |
| Suite 100 | |
| Houston, TX 77007 | |
| Telephone: 832-605-3167 | |
| Contact: Christopher Radzicki | |
| Email: cradzicki@trilliantsurgical.com | |
| Trade Name | Arsenal Plating System |
| Common Name | Bone plate, bone screw, washer |
| Regulation Name | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Smooth or threaded metallic bone fixation fastener | |
| Class | II |
| Product Code | HRS, HWC, NDG |
| CFR Section | 21 CFR Section 888.3030 |
| 21 CFR Section 888.3040 | |
| Device Panel | Orthopedic |
| Predicate Devices | (Primary Predicate) Non-sterile Bone Plate and Screw Implants |
| (Syntec-Taichung Medical Instruments, K983495, HRS & HWC) | |
| ExtremiLOCK Foot Plating System (Osteomed, K131445, HRS) | |
| Gridlock Ankle Plating System (Trilliant Surgical, K160177, HRS & | |
| HWC) | |
| Gridlock Plating System (Trilliant Surgical, K130964, HRS & HWC) |
II. DEVICE DESCRIPTION
The Arsenal Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The system will incorporate multiple locking and non-locking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.
Materials
The implants of the Arsenal Plating System are made from Titanium Alloy (Titanium Ti-6AI-4V ELI, ASTM F-136). Surgical instrumentation is provided to facilitate modification,
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insertion, and removal of the implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymer.
Substantial Equivalence Claimed to Predicate Devices
The Arsenal Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance. The plates of the Arsenal Plating System are manufactured from the same material as the predicate Non-sterile Bone Plate and Screw Implant System from Syntec-Taichung Medical Instruments. The screws of the Arsenal Plating System are manufactured from the same material as the predicate Non-sterile Bone Plate and Screw Implant System from Syntec-Taichung Medical Instruments, Gridlock Plating System from Trilliant Surgical, Gridlock Ankle Plating System from Trilliant Surgical, and ExtremiLOCK Foot Plating System from Osteomed. The Arsenal Plating System is sterilized using the same methods as the listed predicate devices. The technological characteristics and intended use of the proposed device and predicates are identical: all are titanium based plate and screw systems intended to fixate fractures and/or osteotomies of bones appropriate for their size in trauma and reconstructive procedures.
lll. Indications for Use
The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the handfoot, ankle, and other bones appropriate for the size of the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.
IV. Non-Clinical Test Summary
The following tests were performed:
- Single Cycle Bend Testing referencing ASTM F382 .
- . Dynamic Bend Testing referencing ASTM F382
- Axial Pullout Strength Testing referencing ASTM F543
- Torsional Property Testing referencing ASTM F543 .
- . Driving Torque Testing referencing ASTM F543
The results of these evaluations indicate that the Arsenal Plating System is equivalent to the predicate devices.
V. Clinical Test Summary
No clinical studies were performed.
VI. Conclusions: Non-Clinical and Clinical
Trilliant Surgical considers the Arsenal Plating System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.