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)

K250929 · TriMed, Inc. · HRS · Jun 26, 2025 · Orthopedic

Device Facts

• Record ID: K250929
• 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)
• Applicant: TriMed, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

System consists of metallic bone fixation plates and screws for ulnar osteotomy procedures. Plates feature holes for 3.2mm locking and non-locking screws; includes specific lag screw hole for compression across osteotomy site. Used by surgeons in clinical settings to stabilize bone segments post-osteotomy. Device provides mechanical fixation to facilitate bone healing. Output is physical stabilization of the ulna.

Clinical Evidence

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

Technological Characteristics

Medical grade stainless steel; 3.2mm locking and non-locking screws; compression plate design; mechanical fixation.

Indications for Use

Indicated for patients undergoing osteotomy procedures of the ulna.

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 Ulnar Osteotomy Plate (K043263)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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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 ([e-mail]) or phone [phone] 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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TriMed Ulnar Osteotomy System
Page 8 of 33

| 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) | ? |

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510(k) #: K250929
510(k) Summary
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 | [e-mail] |
| 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) |
| K043263 | TriMed Ulnar Osteotomy Plate |
| Product Code | HRS |
| Device Description Summary | 21 CFR 807.92(a)(4) |
| 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. | |
| 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.