(149 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing and pyrogen testing, not algorithmic performance.
Yes
The device is indicated for fixation of hand and foot bone fragments and joint arthrodesis, which are therapeutic interventions.
No
The device is a staple system intended for bone fixation, not for diagnosing medical conditions. Its function is to facilitate the management of bone fractures and reconstructive surgery by providing compression across bone members.
No
The device description clearly states it is a "staple system" and describes physical components ("legs of the implant") and a physical process ("insertion into the prepared bone"). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the TriMAX™ Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "hand and foot bone fragment osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body to fix bones.
- Device Description: The device is a "staple system" used for "bone fixation." This is a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The TriMAX™ Implant System does not perform this function. It is a therapeutic device used in the body.
Therefore, the TriMAX™ Implant System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Product codes
JDR
Device Description
The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstructive surgery. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand 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
Theoretical analysis and mechanical testing was performed to confirm substantial equivalence of the subject TriMAX™ Implant System to the cited predicate. This analysis showed the subject device to be substantially equivalent in terms of performance to the predicate CrossRoads MotoCLIP™/HiMAX Implant System (K181410) and the CrossRoads Screw System (K152072). Thus, it was determined that no additional mechanical testing is required.
Additionally, pyrogen testing was completed to confirm that the TriMAX™ Implant System meets the endotoxin limit of 20 Endotoxin Units (EU)/Device.
Key Metrics
Not Found
Predicate Device(s)
CrossRoads MotoCLIP™/HiMAX Implant System (K181410), CrossRoads Screw System (K152072), Stealth Staple (K153622 and K163440)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
August, 16, 2019
CrossRoads Extemity Systems, LLC % Theresa Leister Senior Consultant Mrc X. LLC 6075 Poplar Avenue Memphis. Tennessee 38119
Re: K190722
Trade/Device Name: TriMAX™ Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: April 8, 2019 Received: July 18, 2019
Dear Theresa Leister:
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.
1
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) 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 (QS) 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 medical devices and radiation-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.
Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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)
Device Name TriMAX™ Implant System
Indications for Use (Describe)
The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
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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510(k) Summary
TriMAX™ Implant System July 17, 2019
| Company: | CrossRoads Extremity Systems, LLC
6055 Primacy Parkway, Suite 140
Memphis, TN 38119 |
|-----------------------------|-------------------------------------------------------------------------------------------|
| Establishment Registration: | 3011421599 |
| Primary Contact: | Theresa Leister
Phone: 901-489-1715 |
| Company Contact: | Chad Hollis
Phone: 901-221-8406 |
| Trade Name: | TriMAX™ Implant System |
| Common Name: | Staple, Fixation, Bone |
| Classification: | Class II |
Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
| Panel: | 87- Orthopedic |
|---|---|
| Product Code: | JDR |
| Predicate Devices: | CrossRoads MotoCLIP™/HiMAX Implant System (K181410) |
| CrossRoads Screw System (K152072) | |
| Stealth Staple (K153622 and K163440) |
Device Description:
The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstructive surgery. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.
4
Indications for Use:
The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Substantial Equivalence:
The subject TriMAX™ Implant System components are substantially equivalent to the following predicate devices:
| Primary Predicate: | CrossRoads MotoCLIP™/HiMAX Implant System (K181410) |
|---|---|
| Secondary Predicate: | CrossRoads Screw System (K152072) |
| Stealth Staple (K153622 & K163440) |
The subject components are similar to the predicate devices in terms of indications, geometry, and materials. Mechanical analysis has shown the subject devices to be substantially equivalent in mechanical strength to the previously cleared CrossRoads MotoCLIP™/HiMAX Implant System (K181410) and the CrossRoads Screw System (K152072). Thus. it can be concluded that the subject devices raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices.
Performance Testing:
Theoretical analysis and mechanical testing was performed to confirm substantial equivalence of the subject TriMAX™ Implant System to the cited predicate. This analysis showed the subject device to be substantially equivalent in terms of performance to the predicate CrossRoads MotoCLIP™/HiMAX Implant System (K181410) and the CrossRoads Screw System (K152072). Thus, it was determined that no additional mechanical testing is required.
Additionally, pyrogen testing was completed to confirm that the TriMAX™ Implant System meets the endotoxin limit of 20 Endotoxin Units (EU)/Device.
Conclusion:
There are no substantial differences between the TriMAX™ Implant System and the predicate devices with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect.
Therefore, the TriMAX™ Implant System is found to be substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.