TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

K251945 · TriMed, Inc. · HRS · Jul 10, 2025 · Orthopedic

Device Facts

• Record ID: K251945
• Device Name: TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
• Applicant: TriMed, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 10, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriMed Total Wrist fusion system is indicated for the following: 1. Wrist arthrodesis 2. Fractures of the wrist 3. Osteotomies of the wrist

Device Story

TriMed Total Wrist Fusion System consists of metallic bone fixation plates and screws; used as aid to bone fixation for fractures, osteotomies, or arthrodesis; implants manufactured from implant-grade stainless steel; system includes straight plates with updated distal ends accepting 2.7mm screws and 3.8mm cancellous screws; device used by surgeons in clinical settings to stabilize bone segments; provides mechanical support to facilitate healing; benefits patient through rigid fixation of wrist anatomy.

Clinical Evidence

No clinical data. Bench testing performed per FDA guidance documents for Orthopedic Fracture Fixation Plates and Orthopedic Non-Spinal Metallic Bone Screws and Washers. All samples met acceptance criteria.

Technological Characteristics

Implant-grade stainless steel; plate and screw fixation; 2.7mm and 3.8mm screw compatibility; mechanical bone fixation appliance.

Indications for Use

Indicated for patients requiring wrist arthrodesis, fixation of wrist fractures, or wrist osteotomies.

Regulatory Classification

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.

Predicate Devices

• TRIMED RADIOCARPAL FUSION SYSTEM (K102785)
• TriMed Ankle Fixation System (K243999)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

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

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K251945 - David Anderson
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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
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

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:
1. Wrist arthrodesis
2. Fractures of the wrist
3. 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)

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| 510(k) #: | 510(k) Summary | Prepared on: 2025-06-24 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | TriMed, Inc. | |
| Applicant Address | 27533 Avenue Hopkins Santa Clarita CA 91355 United States | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Blesson Abraham | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | Tech2Med, LLC | |
| Correspondent Address | 6450 Old Darby TRL NE Ada MI 49301 United States | |
| Correspondent Contact Telephone | [phone] | |
| Correspondent Contact | Mr. David Anderson | |
| Correspondent Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| 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 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. | | |
| 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:
1. Wrist arthrodesis
2. Fractures of the wrist
3. 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. 3.8mm 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.