(30 days)
No
The 510(k) summary describes a mechanical bone fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, which are medical treatments to restore function or correct deformities.
No
This device is an implantable system for bone fixation following fractures or osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a family of physical wedges made of PEEK Optima HA Enhanced with tantalum markers and associated titanium screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Trigon HA Stand-Alone Wedge Fixation System is a surgical implant used for internal bone fixation in the ankle and foot. It is a physical device implanted into the body to provide structural support and stability to fractured or osteotomized bones.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to diagnose or monitor a medical condition. Its function is purely mechanical and structural.
Therefore, the Trigon HA Stand-Alone Wedge Fixation System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- · Subtalar Fusion
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- · Calcaneocuboid Arthrodesis
- · Z-Calcaneal Lengthening Osteotomies
- · MTP Lengthening Arthrodesis
The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
PLF, HWC, HRS
Device Description
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, and MTP Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle and foot
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System. The following was performed to demonstrate safety per methods of the previous submission:
- . Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)
The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices.
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.
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.
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
January 26, 2024
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nvision Biomedical Technologies Analaura Villarreal Berain Project Manager 4590 Lockhill Selma San Antonio, Texas 78249
Re: K234116
Trade/Device Name: Trigon Trigon HA Stand-Alone Wedge Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PLF, HWC, HRS Dated: December 5, 2023 Received: December 27, 2023
Dear Analaura Villarreal Berain:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K234116
Device Name
Trigon HA Stand-Alone Wedge Fixation System
Indications for Use (Describe)
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- · Subtalar Fusion
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- · Calcaneocuboid Arthrodesis
- · Z-Calcaneal Lengthening Osteotomies
- · MTP Lengthening Arthrodesis
The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.
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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3
510(k) Summary K234116
DATE PREPARED
January 25, 2024
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Analaura Villarreal-Berain, Engineering Project Manager Telephone: (210) 545-3713 Email: analauravillarreal@nvisionbiomed.com
PROPRIETARY NAME OF SUBJECT DEVICE
Trigon™ HA Stand-Alone Wedge Fixation System
COMMON NAME
- Primary Bone Wedge
- Screw, Fixation, Bone ●
- Plate, Fixation, Bone ●
DEVICE CLASSIFICATION
| Device | Product Code | Classification Regulation | Class |
|---|---|---|---|
| Primary | |||
| Bone Wedge | Primary PLF | Primary 21 CFR 888.3030 | |
| Single/multiple components metallic bone | |||
| fixation appliances and accessories | II | ||
| Bone Screw | HWC | 21 CFR 888.3040 | |
| Smooth or threaded metallic bone fixation | |||
| fastener | II | ||
| Bone Plate | HRS | 21 CFR 888.3030 | |
| Single/multiple components metallic bone | |||
| fixation appliances and accessories | II |
PREMARKET REVIEW
Orthopedic Devices
4
INDICATIONS FOR USE
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- Subtalar Fusion
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- · Calcaneocuboid Arthrodesis
- · Calcaneal Z Lengthening Osteotomies
- · MTP Lengthening Arthrodesis
The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.
DEVICE DESCRIPTION
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, and MTP Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
PREDICATE DEVICE IDENTIFICATION
The subject Trigon™ HA Stand-Alone Wedge Fixation System is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate |
|---|---|---|
| K220197 | Nvision Biomedical's Trigon™ HA Stand-Alone Wedge | |
| Fixation System | Primary | |
| K193414 | Nvision Biomedical's Trigon™ HA Stand-Alone Wedge | |
| Fixation System | Additional |
Nvision Biomedical's nva, nvp, nvt (K193645) is also cited in this submission as a reference predicate device.
5
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System. The following was performed to demonstrate safety per methods of the previous submission:
- . Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)
The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the Trigon HA Stand-Alone Wedge Fixation System modification is substantially equivalent to the predicate devices. The subject implants maintain the same features as the previously cleared devices with an addition of configurations for different foot procedures commonly performed. This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence. These technological characteristics have undergone a comparison of characteristics to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the comparison of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Trigon HA Stand-Alone Wedge Fixation System options are assessed to be substantially equivalent to the predicate devices.