(60 days)
Not Found
No
The 510(k) summary describes a system of plates and screws for bone fixation and mentions only mechanical testing, with no indication of software, image processing, or AI/ML components.
Yes
The device is indicated for fractures, osteotomies, and non-unions of the distal tibia, which are medical conditions that require treatment. It is also a fixation system, which implies a therapeutic intervention.
No
The device is a fixation system (plates and screws) used for treating fractures, osteotomies, and non-unions, not for diagnosing medical conditions.
No
The device description explicitly states that the device consists of plates and screws manufactured from medical grade stainless steel, which are hardware components.
Based on the provided information, the TriMed Posterior Malleolus Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fixing fractures, osteotomies, and non-unions of the distal tibia. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws made of stainless steel, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. The TriMed Posterior Malleolus Fixation System is a surgical implant used to stabilize bone.
N/A
Intended Use / Indications for Use
TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia.
Product codes
HRS, HWC
Device Description
TriMed Posterior Malleolus Fixation System plates and screws are manufactured from medical grade stainless steel. Posterior Malleolar L-Plates and T-Plates accept 2.7mm and 3.2mm locking and non-locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia
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 Posterior Malleolus Plates and Predicate plates (Synthes Distal Tibia T-Plates) were subjected to static and endurance testing. TriMed Posterior Malleolar plates exhibited superior performance when compared to a predicate device (Synthes Distal Tibia T-Plates) during static testing when compared to a predicate device.
TriMed Posterior Malleolus Fixation 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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
November 26, 2024
TriMed. Inc. Divya Raghavi Nandakumar Regulatory Affairs Supervisor 27533 Avenue Hopkins Santa Clarita, California 91355
Re: K243050
Trade/Device Name: TriMed Posterior Malleolus Fixation System 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: September 27, 2024 Received: September 27, 2024
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory
2
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, MS Assistant Director, Biomedical Engineer 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
TriMed Posterior Malleolus Fixation System
Indications for Use (Describe)
TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| | P | 4
1000
100 |
|--|---|------------------|
| | | |
510(k) Summary
Prepared on: 2024-09-27
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(6)
| 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 |
21 CFR 807.92(a)(1)
| Device Name | 21 CFR 807.92(a)(2) | |
|---|---|---|
| Device Trade Name | TriMed Posterior Malleolus Fixation System | |
| Common Name | Plate, Fixation, Bone (primary) | |
| Screw, Fixation, Bone | ||
| Classification Name | Single/multiple component metallic bone fixation appliances and | |
| accessories (primary) | ||
| Smooth or threaded metallic bone fixation fastener | ||
| Regulation Number | 888.3030 (primary), 888.3040 | |
| Product Code(s) | HRS (primary), HWC |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K080522 | Synthes 3.5mm LCP Distal Tibia T Plates | HRS |
21 CFR 807.92(a)(4)
Device Description Summary
TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia. TriMed Posterior
Malleolus Fixation System plates and screws are manufactured from medical grade stainless steel. Posterior Malleolar L-Plates and T-
Plates accept 2.7mm and 3.2mm locking and non-locking screws.
21 CFR 807.92(a)(5)
Intended Use/Indications for Use
TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia.
21 CFR 807.92(a)(5)
Indications for Use ComparisonBoth TriMed Posterior Malleolus Fixation system and the predicated for treatment of fractures, osteotomies and nonunions in the distal tibia. The predications for use statement highlights "osteopenic bone". Difference between the two indications for use statements is very minor. The difference does not constitute a new intended use.
Technological Comparison
TriMed Posterior Malleolus Fixation System is substantially equivalent to Synthes 3.5mm LCP Distal Tibia T Plates (predicate) in terms of material, design features, principles of operation, 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.
5
TriMed Posterior Malleolus Plates and Predicate plates (Synthes Distal Tibia T-Plates) were subjected to static and endurance testing. TriMed Posterior Malleolar plates exhibited superior performance when compared to a predicate device (Synthes Distal Tibia T-Plates) during static testing when compared to a predicate device.
TriMed Posterior Malleolus Fixation 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.
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 Malleolus Fixation System devices are substantially equivalent to the predicate device (Synthes 3.5mm LCP Distal Tibia T Plates) cleared under K080522.