(210 days)
No
The summary describes a system of physical plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a plating system intended for fixation, reduction, fusion, and stabilization of bones and bone fragments. This is a structural and mechanical support function, not a therapeutic one (i.e., it does not treat a disease or condition).
No
This device is a plating system used for fixation of bones and bone fragments, which falls under therapeutic/surgical devices, not diagnostic ones.
No
The device description explicitly states the system consists of implantable devices (plates and screws), which are hardware components.
No, 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: The TRILEAP Plating System is a system of implantable devices (plates and screws) used for the physical fixation and stabilization of bones.
- Intended Use: The intended use is for the surgical fixation of bones and bone fragments in the foot and ankle. This is a surgical procedure, not a diagnostic test performed on a sample.
The provided information clearly describes a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The TRILEAP™ Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.
Product codes
HRS, HWC
Device Description
The TRILEAP Plating System is intended for reduction, temporary fixation, fusion and stabilization of bones. The system consists of a family of implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure specific plates, cortical screws, and variable angle locking screws available in various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and bone fragments of the foot and ankle
Indicated Patient Age Range
adults and adolescents (aged 12 -21 years) where the growth plates have fused.
Intended User / Care Setting
Prescription Use
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
The following analyses were conducted for TRILEAP Plating System. Screw testing utilized acceptance criteria from the FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)".
• Plate Cross-Section Analysis (Bending Strength)
• Screw Torsional Strength Analysis according to ASTM F543 via a Finite Element Analysis model
• Screw Driving Torque according to ASTM F543
Screw Pull-Out via the Chapman Equation
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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
September 29, 2023
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
CrossRoads Extremity Systems Keith Knapp Regulatory Affairs Specialist 6423 Shelby View Dr., Suite 101 Memphis, Tennessee 38134
Re: K230591
Trade/Device Name: TRILEAP 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: August 14, 2023 Received: August 23, 2023
Dear Keith Knapp:
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.
1
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). 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 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,
Tejen D. Soni -S
For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair
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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) K230591
Device Name TRILEAP Plating System
Indications for Use (Describe)
The TRILEAP™ Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of a square made up of four smaller squares in the colors blue and green. To the right of the square is the word "CrossRoads" in gray, with the trademark symbol in the upper right corner. Below the word "CrossRoads" is the phrase "Extremity Systems" in a smaller font, also in gray.
510(k) Summary
| Sponsor | CrossRoads Extremity Systems, LLC
Keith Knapp
6423 Shelby View Dr, Suite 101
Memphis, TN, 38134, USA
Phone: +1-610-719-5942 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 03/02/2023 |
| Proprietary Name | TRILEAP Plating System |
| Device Common
Name | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Name | Single/multiple component metallic bone fixation appliances and
accessories. (Primary)
Smooth or threaded metallic bone fixation fastener. |
| Classification | Class II
Regulation Number: 21 CFR 888.3030 (Primary) & 888.3040
Product Code: HRS (Primary), HWC |
| Primary Predicate
Devices | Synthes 2.4mm/2.7 mm Variable Angle LCP forefoot/ Midfoot System
(K100776) |
| Additional Predicate
Devices | MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion
System, DynaMET™ Lesser TMT Fusion System (K223342) |
| Device Description | The TRILEAP Plating System is intended for reduction, temporary fixation,
fusion and stabilization of bones. The system consists of a family of
implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm
non-contoured and anatomic procedure specific plates, cortical screws, and
variable angle locking screws available in various sizes. |
| Indications for use | The TRILEAP™ Plating System is indicated for fixation of bones and bone
fragments of the foot and ankle in adults and adolescents (aged 12 -21
years) where the growth plates have fused. |
| Non-clinical
Performance Data | The following analyses were conducted for TRILEAP Plating System. Screw
testing utilized acceptance criteria from the FDA Guidance, "Orthopedic
Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for
Safety and Performance Based Pathway (December 2020)".
• Plate Cross-Section Analysis (Bending Strength)
• Screw Torsional Strength Analysis according to ASTM F543 via a
Finite Element Analysis model
• Screw Driving Torque according to ASTM F543 |
| | Screw Pull-Out via the Chapman Equation |
| Clinical
Performance Data | Clinical testing was not necessary for the determination of substantial
equivalence. |
| Substantial
Equivalence | The proposed subject devices have the same intended uses as the predicate
devices. The proposed subject devices share similar indications, are similar
in design, material, and fundamental technology with the identified
predicate devices. |
| | The testing and analytical evaluation included in this submission
demonstrate that: Any differences in technological characteristics of the predicate
devices do not raise any new questions of safety and effectiveness The proposed devices are at least as safe and effective as the
predicate devices |
| Conclusion | In conclusion, the results of non-clinical performance data demonstrate that
the subject devices are substantially equivalent with the predicate devices. |
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Image /page/5/Picture/1 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of four squares in the upper left corner, with the top left square being blue, the top right square being green, the bottom left square being green, and the bottom right square being light blue. To the right of the squares is the text "CrossRoads" in gray, with the trademark symbol next to it. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller font and also in gray.