The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.

Device Description

TriMed Ankle Fixation System (AFS) is a comprehensive ankle fracture fixation system intended to aid the treatment of certain types of fractures, malunions, and non-union of the tibia and fibula. The system is designed to constraint movement between bone surfaces and is intended only as an aid to fix the fracture in place during the healing process.

The system implants consist of plates, screws and wire form devices and supporting instrumentation. The implants vary in designs, and sizes to accommodate patient size, anatomy and fracture type. The implants manufactured from 316L medical grade stainless steel per ASTM F138 or F139.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TriMed Ankle Fixation System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA's letter (K243999) on the TriMed Ankle Fixation System indicates that the device's performance was evaluated against established standards and guidance documents. The acceptance criteria are implicitly defined by these standards, with the reported performance being that the device met or exceeded them.

Acceptance Criteria (Defined by Standard/Guidance)	Reported Device Performance
Mechanical Performance (Screws): ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) and FDA Guidance (Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway)	Performed equivalent or better in comparison to the predicate device.
Mechanical Performance (Plates): ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates)	Performed equivalent or better in comparison to the predicate device.

Regarding the Predetermined Change Control Plan (PCCP) specifically for combining the Medial Malleolar Sled and Washer:

Acceptance Criteria (Planned Modification)	Reported Device Performance
Biocompatibility and Sterilization: To meet the same requirements as set for the original TriMed Ankle Fixation System.	The document states these will be conducted to the same requirements, implying they will meet these requirements upon implementation of the change.
Mechanical Performance (Combined Sled and Washer): Construct Static bend and endurance bend testing (per Medial Malleolar Sled Static and Endurance Test Plan Rev 1.0) will be performed to verify the mechanical performance for fracture fixation.	The document states these tests will be performed to verify mechanical performance, implying they are the acceptance criteria for this specific change. The actual performance data is not yet available as this is a future planned modification.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the mechanical testing mentioned (ASTM F543-17, FDA Guidance, ASTM F382). These standards typically define sample size requirements. The data provenance is implied to be from TriMed, Inc.'s internal testing, as it's a premarket notification for their device. No specific country of origin for the data is mentioned, but the submitter is based in Santa Clarita, California, USA. The studies are retrospective in the sense that they were conducted to support the 510(k) submission for an existing device or a planned modification.

3. Number of Experts and Qualifications for Ground Truth

This document describes pre-market device clearance based on mechanical testing and equivalence to predicate devices, not on diagnostic performance where expert ground truth establishment would be relevant. Therefore, there are no experts referenced for establishing ground truth as this is primarily a hardware/material performance evaluation.

4. Adjudication Method for Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation (e.g., image-based diagnostics) to establish a consensus ground truth. This submission focuses on the mechanical and material properties of a surgical implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating the impact of AI systems on human readers' diagnostic performance. This document concerns a physical medical device (ankle fixation system) and its mechanical performance, not an AI or diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. This is not an algorithm or software device.

7. Type of Ground Truth Used

The "ground truth" for the TriMed Ankle Fixation System's mechanical performance is defined by the standards and guidance documents (e.g., ASTM F543-17, ASTM F382) that specify acceptable mechanical properties and testing methodologies. The device's performance is then compared to these established benchmarks and to predicate devices rather than clinical outcomes or pathology reports in the context of this 510(k) summary. For the Predetermined Change Control Plan, the ground truth for performance verification will be the results of the specified static bend and endurance bend testing.

8. Sample Size for the Training Set

Not applicable. There is no AI/machine learning component involved that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied.

Summary

{0}------------------------------------------------

March 19, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a stylized human figure on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" being larger and bolder than the rest of the text. The human figure is a symbol representing health and well-being.

TriMed. Inc. Divya Raghavi Nandakumar Regulatory Affairs Supervisor 27533 Avenue Hopkins Santa Clarita, Texas 91355

Re: K243999

Trade/Device Name: TriMed Ankle 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: HRS, HWC, NDL, NDG Dated: December 24, 2024 Received: December 26, 2024

Dear Divya Raghavi Nandakumar:

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}------------------------------------------------

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP) titled "K243999 – Predetermined Change Control Plan – AFS 10MAR2025.pdf'. Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could sigmificantly affect the safety or effectiveness of the device. e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(0) of the Act, respectively.

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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these

{2}------------------------------------------------

requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira. MS 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

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K243999

Device Name

TriMed Ankle Fixation System

Indications for Use (Describe)

The TriMed Sidewinder and Cluster Plates are indicated for fractures, non-unions & osteotomies of the distal fibula.

The TriMed Straight Plates and Ankle Hook Plates are indicated for fractures, non-unions & osteotomies of the distal fibula and distal tibia.

The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for TriMed. The logo consists of a blue symbol that looks like two interlocking umbrellas, followed by the word "TriMed" in blue. A registered trademark symbol is located to the right of the word "TriMed".

Corporate Office

27533 Avenue Hopkins
Valencia, CA 91355

800-633-7221 Phone 661-255-7406 Office
661-254-8485 Fax

K243999

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Information	21 CFR 807.92(a)(1)
Submitter:	TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355 USAPhone: 1-661-255-7406Establishment Registration Number: 2031009
Contact Person:	Divya Raghavi NandakumarRegulatory Affairs SupervisorPhone: 1-661-255-7406Email: divyarnandakumar@trimedortho.com
Date Prepared:	March 14, 2025
Device Information	21 CFR 807.92(a)(2)

Trade Name:	TriMed® Ankle Fixation System
Common Name:	Ankle Plating System
Regulation Number:	21 CFR 888.3030
Regulation Name:	Single/multiple component metallic bone fixation appliances and accessories.
Classification:	Class II
Product Code:	HRS, HWC, NDL, NDG
Review Panel:	Orthopedic

Legally Marketed Predicate Device(s)

21 CFR 807.92(a)(3)

Primary Predicate:	K060041 – TriMed Bone Plates (21 CFR 888.3030; HRS; Class II)
Additional Predicate(s):	K010545 – Tension Band Wire (21 CFR 888.3040; NDL; Class II)
	K143385 – Acumed Ankle Plating System (21 CFR 888.3030; HRS; Class II)

{5}------------------------------------------------

Corporate Office

27533 Avenue Hopkins

661-255-7406 Offic

K243999

Device Description

Intended Use / Indications for Use	21 CFR 807.92(a)(5)
------------------------------------	---------------------

The TriMed Sidewinder and Cluster Plates are indicated for fractures, non-unions & osteotomies of the distal fibula.

The TriMed Straight Plates and Ankle Hook Plates are indicated for fractures, non-unions & osteotomies of the distal fibula and distal tibia.

The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.

Comparison of Technological Characteristics	21 CFR 807.92(a)(6)
---------------------------------------------	---------------------

The TriMed Ankle Fixation System has the basic design features and intended use as the predicate device. Any differences between them are considered minor and do not raise questions concerning safety or effectiveness. Based on the information provided, TriMed has determined that the proposed device is substantially equivalent to the predicate device.

Non-Clinical Summary & Conclusions

Mechanical performance of the TriMed Ankle Fixation System was established in accordance with the below standards/guidance in comparison to the predicate device.

ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws.
FDA Guidance, Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance ● Criteria for Safety and Performance Based Pathway.
ASTM F382, Standard Specification and Test Method for Metallic Bone Plates.

The TriMed Ankle Fixation System performed equivalent or better in comparison to the predicate device.

Image /page/5/Picture/20 description: The image contains the logo for TriMed. The logo consists of a blue symbol resembling an umbrella or a stylized 'T' and 'M' intertwined. To the right of the symbol, the word "TriMed" is written in a sans-serif font, also in blue. A small registration mark is present next to the 'd' in "TriMed".

21 CFR 807.92(a)(4)

estions concerning

21 CFR 807.92(b)

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for TriMed. The logo consists of a blue symbol that looks like three interconnected arches, with a horizontal line underneath. To the right of the symbol is the word "TriMed" in blue, with a registered trademark symbol next to it.

Corporate Office

27533 Avenue Hopkins Valencia. CA 91355

K243999

800-633-7221 Phone 661-255-7406 Office 1-254-8485 Fax

Conclusion

Substantial equivalence of the subject TriMed Ankle Fixation to the predicate TriMed Bone Plate devices is based on the following:

Both devices have the same intended use.
Both devices have the same fundamental scientific technology and principles of operation.
. Both devices share similar functional and technological characteristics.

Evaluation of the associated risks do not raise different questions of safety or effectiveness. Performance data referenced in this 510(k) submission demonstrates that the subject TriMed Ankle Fixation System is safe and effective for its intended use and is substantially equivalent to the predicate device.

Predetermined Change Control Plan (PCCP)

This submission includes a Predetermined Change Control Plan (PCCP) for TriMed Ankle Fixation System, Medial Malleolar Sled and Washer components. The PCCP establishes a comprehensive framework for managing a pre-planned modification, which includes releasing a design that combines the Medial Malleolar Sled and Washer into a single device. It also details the methods for implementing these modifications. A summary of the proposed modifications, testing methods, validation activities, and user communication is provided in the table below.

PlannedModifications	Test Methods and Validation Activities	Communication to Users, asNeeded
Combine theMedialMalleolar Sledand Washerdevices into asingle device.	Biocompatibility and Sterilization will beconducted to the same requirements as setfor the TriMed Ankle Fixation SystemConstruct Static bend and endurance bendtesting (per Medial Malleolar Sled Static andEndurance Test Plan Rev 1.0) will beperformed to verify the mechanicalperformance for fracture fixation.	Labeling will be updated inaccordance with the authorizedPCCP to provide users withcurrent information regardingthe device material composition.

Regulation Number and Section

§ 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.