(120 days)
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI/ML terms or functionalities.
No.
The device is an implant for mechanical fixation, which is a structural rather than a therapeutic function.
No
The device is described as a "Minimally Invasive Bunion Plating System" intended for "fixation of osteotomies and corrective procedures," which indicates it is a surgical implant/fixation device, not a device used to diagnose a medical condition.
No
The device description explicitly states it consists of physical components like plates, screws, and instruments, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Minimally Invasive Bunion Plating System is a surgical implant (plates and screws) used to fix bones during surgery. It is physically implanted into the body.
- Intended Use: The intended use is for "fixation of osteotomies and corrective procedures of the hallux," which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
Product codes
HRS
Device Description
The Minimally Invasive Bunion Plating System consists of left and right plates composed of implant grade titanium intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The system will incorporate both locking and non-locking screws, cannulated screws, 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
hallux
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
No clinical studies were performed.
Non-Clinical Test Summary:
- Single Cycle Bend Testing referencing ASTM F382
- Dynamic Bend Testing referencing ASTM F382
The results of these evaluations indicate that the Minimally Invasive Bunion Plating System is equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Gridlock Plating System (Trilliant Surgical LTD, K121452), Mini MaxLock Extreme Plating System - ISO Plate (OrthoHelix/Tornier, K121437)
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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November 16, 2017
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Trilliant Surgical, LTD Jonathan Olson President 6721 Portwest Drive, Suite 160 Houston, Texas 77024
Re: K172178
Trade/Device Name: Minimally Invasive Bunion 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 Dated: October 10, 2017 Received: October 10, 2017
Dear Jonathan Olson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Minimally Invasive Bunion Plating System
Indications for Use (Describe)
The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
| 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 Minimally Invasive Bunion 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 Minimally Invasive Bunion Plating System.
l. GENERAL INFORMATION
| Date Prepared | July 14th, 2017 |
|---|---|
| Submitted By | Trilliant Surgical LTD |
| 6721 Portwest Dr. | |
| Suite 160 | |
| Houston, TX 77024 | |
| Telephone: 713-388-6055 | |
| Contact: Jon Olson | |
| Email: jolson@trilliantsurgical.com | |
| Trade Name | Minimally Invasive Bunion Plating System |
| Common Name | bone fixation plate |
| Classification Name | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Class | II |
| Product Code | HRS |
| CFR Section | 21 CFR Section 888.3030 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Gridlock Plating System (Trilliant Surgical LTD, K121452) |
| Secondary Predicate | |
| Device | Mini MaxLock Extreme Plating System - ISO Plate |
| (OrthoHelix/Tornier, K121437) |
II. DEVICE DESCRIPTION
The Minimally Invasive Bunion Plating System consists of left and right plates composed of implant grade titanium intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The system will incorporate both locking and non-locking screws, cannulated screws, and the necessary instruments to facilitate the placement of these implants.
Materials
CP Titanium per ASTM F67
Substantial Equivalence Claimed to Predicate Devices
The Minimally Invasive Bunion Plating System is substantially equivalent to the predicate device in terms of intended use, design, materials used, mechanical safety and performance. The plates of the Minimally Invasive Bunion Plating System are manufactured from the same material and utilize the same screws as the predicate Gridlock Plating System. The Minimally Invasive Bunion Plating System is sterilized using the same methods as the predicate Gridlock Plating System. The technological
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characteristics of the proposed device and the predicates are similar: all are titanium based plate and screw systems intended to fix fractures and/or osteotomies of bones appropriate for their size.
lll. Indications for Use
The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
IV. Non-Clinical Test Summary
The following tests were performed:
- Single Cycle Bend Testing referencing ASTM F382 ●
- Dynamic Bend Testing referencing ASTM F382 .
The results of these evaluations indicate that the Minimally Invasive Bunion 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 LTD considers the Minimally Invasive Bunion 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.