(90 days)
Not Found
No.
The document describes a medical device (plates and screws for ulna osteotomy) and does not mention any software, data processing, or AI/ML components. It focuses on the physical components and their mechanical testing.
No
The device, TriMed Ulnar Osteotomy Plates, is used in osteotomy procedures of the Ulna, which are surgical procedures to cut and reshape bones. Its function is to fix bones during the healing process after such a procedure, rather than to treat a disease or condition itself.
No
The device is a surgical plate and screw system used for osteotomy procedures, which is a treatment, not a diagnostic process.
No
The device is a system of physical plates and screws (hardware) made from medical grade stainless steel, intended for surgical procedures. It is not a software-only medical device.
No
The device is a surgical implant (plates and screws) used in osteotomy procedures, which is an in-vivo application, not an in-vitro diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ulna
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
Page 4
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
Page 5
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)
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)
Page 6
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.