TriMed Ulnar Osteosystem System includes plates and screws indicated for osteotomies of the ulna. TriMed Ulnar Osteotomy System plates and screws are manufactured from medical grade stainless steel. Ulnar Osteotomy Compression Plates accept 3.2mm locking and non-locking screws. The lag screw hole in the plate accepts a 3.2mm lag screw that helps achieve additional compression across the osteotomy site.

AI/ML Overview

This 510(k) clearance letter pertains to a medical device, specifically an Ulnar Osteotomy System (plates and screws), not an AI/software device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/software device meets those criteria (such as MRMC studies, ground truth establishment for AI training sets, sample sizes for test sets, expert consensus, etc.) is not applicable to this document.

The document discusses non-clinical testing performed on the physical implants (plates and screws) to demonstrate their safety and effectiveness.

Here's a breakdown of the relevant information provided in the letter regarding how the device meets acceptance criteria:

Acceptance Criteria and Device Performance (for a Medical Device - Implants)

Since this is a physical medical device (implants), the acceptance criteria are met through non-clinical testing (mechanical, material, and performance testing) rather than clinical studies or AI algorithm performance metrics.

1. A table of acceptance criteria and the reported device performance:

The document broadly states that the devices met acceptance criteria based on established FDA guidance documents for orthopedic implants. A detailed table of specific acceptance criteria values and reported performance values is not provided in this summary, as it would typically be part of the full submission, not the clearance letter.

Acceptance Criteria Category	Guidance Document Cited	Reported Performance
Ulnar Osteotomy Plates	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."
Ulnar Osteotomy Screws	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."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the clearance letter. For non-clinical testing of medical devices, sample sizes are typically determined by statistical rationale to demonstrate a high degree of confidence in the device's performance, but specific numbers are not always included in the public-facing clearance summary.
Data Provenance: Not applicable in the context of clinical data for AI. This refers to laboratory non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This is not an AI/software device. The "ground truth" for physical implants is established through engineering standards, material science, and biomechanical principles, not expert human interpretation of images or clinical outcomes in the same way as AI.

4. Adjudication method for the test set:

Not Applicable: This pertains to clinical data interpretation or AI model output, not mechanical testing of physical implants. The "adjudication" for mechanical tests would involve adherence to standardized test protocols and data analysis by qualified engineers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No: This type of study is relevant for diagnostic AI/software to assess human reader performance with and without AI assistance. Clinical studies, including MRMC, were explicitly not conducted for these physical devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable: This is an AI/software concept. The device is a set of physical implants.

7. The type of ground truth used:

Engineering Standards and Biomechanical Principles: For physical implants, "ground truth" refers to meeting established performance benchmarks (e.g., strength, fatigue resistance, corrosion resistance) as defined by international and national standards (like ASTM, ISO) and specific FDA guidance documents for orthopedic devices. The materials used (medical grade stainless steel) and manufacturing processes also form part of this "ground truth" for safety and effectiveness.

8. The sample size for the training set:

Not Applicable: This is for AI/software. The design and manufacturing of physical implants do not involve "training sets" in the AI sense.

9. How the ground truth for the training set was established:

Not Applicable: As above, this is an AI/software concept. For physical devices, design validation and verification against engineering requirements and established specifications are the equivalent processes.

Summary of the Study Proving the Device Meets Acceptance Criteria (as described in this document):

The manufacturer, TriMed, Inc., performed non-clinical tests on the TriMed Ulnar Osteotomy System components (plates and screws). These tests were conducted according to the recommendations and criteria outlined in specific FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws.

Ulnar Osteotomy Plates: Tested per "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff."
Ulnar Osteotomy Screws: Tested per "Orthopedic Non-Spinal Metallic Bone Screws and Washers –Performance Criteria for Safety and Performance Based Pathway."

The core finding reported is that "All test samples met the acceptance criteria" for both the plates and screws, as specified in the respective FDA guidance documents. This indicates that the physical and mechanical properties of the devices (e.g., strength, fatigue life, material compatibility) were demonstrated to be safe and effective for their intended surgical use, based on these standardized engineering tests.

Clinical studies were explicitly stated as "not conducted" for these devices, meaning the clearance was based entirely on the non-clinical (laboratory) testing, comparison to a predicate device, and the established regulatory pathway for such orthopedic implants.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

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

Doc ID # 04017.07.05

June 26, 2025

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

Re: K250929

Trade/Device Name: TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

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: March 19, 2025
Received: March 28, 2025

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

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K250929 - Divya Raghavi Nandakumar
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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K250929 - Divya Raghavi Nandakumar
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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-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,

CHRISTOPHER FERREIRA -S

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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K250929

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K250929
Please provide the device trade name(s).

TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate);
TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm);
TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm);
TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

Please provide your Indications for Use below.

TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

Please select the types of uses (select one or both, as applicable).	☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

TriMed Ulnar Osteotomy System
Page 8 of 33

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K250929

510(k) Summary

510(k)#: K250929
Prepared on: 2025-03-27

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	6612557406
Applicant Contact	Mrs. Divya Raghavi Nandakumar
Applicant Contact Email	divyarnandakumar@trimedortho.com

Device Name

21 CFR 807.92(a)(2)

Device Trade Name	TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate);TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm);TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm);TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
Common Name	Single/multiple component metallic bone fixation appliances and accessories
Classification Name	Plate, Fixation, Bone (primary)Screw, Fixation, Bone
Regulation Number	888.3030 (primary), 888.3040
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
K043263	TriMed Ulnar Osteotomy Plate	HRS

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

Indications for Use Comparison

21 CFR 807.92(a)(5)

Both TriMed Ulnar Osteotomy System and the predicate device are indicated for use in osteotomy procedures of the Ulna. The indications for use statements are the same.

Technological Comparison

21 CFR 807.92(a)(6)

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TriMed Ulnar Osteotomy System is substantially equivalent to predicate device in terms of material, design features, principles of operation, manufacturing, packaging, and labeling. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

TriMed Ulnar Osteotomy 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 Ulnar Osteotomy 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.

Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed,Inc. has determined that TriMed Ulnar Osteotomy System devices are substantially equivalent to the predicate device cleared under K043263.

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.