The TriMed Total Wrist Fusion products are devices which are to be used as an aid to fixation of bone for treatment of certain fractures, osteotomies, or arthrodesis that lend themselves to the principle of plate and/or screw fixation.

The TriMed Total Wrist Fusion System implants are made from implant grade stainless steel.

AI/ML Overview

The provided FDA 510(k) clearance letter is for a medical device (TriMed Total Wrist Fusion System) andではありません a software/AI product. Therefore, the questions related to acceptance criteria, study details, expert involvement, and ground truth establishment for AI performance are not directly applicable.

However, I can extract the information relevant to the device's testing and acceptance criteria as described in the document, which focuses on mechanical performance rather than AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Defined by FDA Guidance Document: "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway"	"All test samples met the acceptance criteria."
Defined by FDA Guidance Document: "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway"	"All test samples met the acceptance criteria."

Note: The specific numerical or qualitative acceptance criteria from these guidance documents are not detailed in the provided FDA letter. The letter only states that the device met them.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "All test samples," indicating that a set of samples were tested, but the exact number is not provided.
Data Provenance: Not applicable in the context of clinical data for AI. For mechanical testing, the data would originate from laboratory testing of manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

4. Adjudication Method for the Test Set

Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states: "Clinical studies were not conducted for the subject devices." MRMC studies are typically for evaluating the clinical effectiveness of diagnostic tools, often involving AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This refers to AI algorithm performance. The device is a physical fusion system.

7. The Type of Ground Truth Used

For mechanical testing: The "ground truth" implicitly refers to the specified performance requirements and limits outlined in the FDA guidance documents (e.g., strength, fatigue life, stiffness). The device's performance is measured against these engineering standards.

8. The Sample Size for the Training Set

Not applicable. This refers to AI model training data.

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

Not applicable. This refers to AI model training data.

Summary specific to the provided document:

The TriMed Total Wrist Fusion System underwent non-clinical (mechanical) testing based on FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws/washers. The key finding is that all tested samples of the device met the specified acceptance criteria outlined in these guidance documents. No clinical studies were performed. The "ground truth" in this context refers to the engineering performance standards set by the FDA for such devices.

Summary

FDA 510(k) Clearance Letter - TriMed Total Wrist Fusion System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 10, 2025

TriMed, Inc.
℅ David Anderson
Regulatory Consultant
Tech2Med, LLC
6450 Old Darby TRL NE
Ada, Michigan 49301

Re: K251945
Trade/Device Name: TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
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: June 24, 2025
Received: June 25, 2025

Dear David Anderson:

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.

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K251945 - David Anderson Page 2

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 (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-reporting-combination-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 Rule"). 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 requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251945 - David Anderson Page 3

assistance/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,

Thomas Mcnamara -S

For: Christopher Ferreira, M.S.
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K251945

Device Name
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

Indications for Use (Describe)
The TriMed Total Wrist fusion system is indicated for the following:

Wrist arthrodesis
Fractures of the wrist
Osteotomies of the wrist

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)

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:

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510(k) Summary

Prepared on: 2025-06-24

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	TriMed, Inc.
Applicant Address	27533 Avenue Hopkins Santa Clarita CA 91355 United States
Applicant Contact Telephone	(979) 204-4952
Applicant Contact	Mr. Blesson Abraham
Applicant Contact Email	Blesson.Abraham@henryschein.com
Correspondent Name	Tech2Med, LLC
Correspondent Address	6450 Old Darby TRL NE Ada MI 49301 United States
Correspondent Contact Telephone	(574) 377-0111
Correspondent Contact	Mr. David Anderson
Correspondent Contact Email	david.anderson@tech2md.com

Device Name

21 CFR 807.92(a)(2)

Field	Information
Device Trade Name	TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
Common Name	Single/multiple component metallic bone fixation appliances and
Classification Name	Plate, Fixation, Bone
Regulation Number	888.3030
Product Code(s)	HRS, HWC

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K102785	TRIMED RADIOCARPAL FUSION SYSTEM	HRS
K243999	TriMed Ankle Fixation System	HRS

Device Description Summary

21 CFR 807.92(a)(4)

The TriMed Total Wrist Fusion System implants are made from implant grade stainless steel.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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The TriMed Total Wrist fusion system is indicated for the following:

Wrist arthrodesis
Fractures of the wrist
Osteotomies of the wrist

Indications for Use Comparison

21 CFR 807.92(a)(5)

The original indications for use cleared under K102785 stated that the Radiocarpal Fusions System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones. Current labeling for the TriMed Total Wrist Fusion System states The TriMed Total Wrist fusion system is indicated for the following:
• Wrist arthrodesis
• Fractures of the wrist
• Osteotomies of the wrist

The addition of osteotomies to the indications does not constitute a change as an osteotomy is a controlled fracture.

Technological Comparison

21 CFR 807.92(a)(6)

The updated TriMed Total Wrist Fusion plates have minor modifications to plate length. The TriMed Total Wrist Fusion Straight Plate has an updated distal end that accepts 2.7mm screws. 2.8mm cancellous screws are included for all system plates.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

TriMed Total Wrist Fusion Plates were tested per the recommendations cited in the FDA Guidance Document, Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. All test samples met the acceptance criteria.

TriMed Total Wrist Fusion System screws were tested per the recommendations cited in the FDA Guidance Document, Orthopedic Non-Spinal Metallic Bone Screws and Washers –Performance Criteria for Safety and Performance Based Pathway. All test samples met the acceptance criteria.

Clinical studies were not conducted for the subject devices.

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.