(86 days)
Not Found
No
The summary describes a system of bone plates, wire forms, and screws for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making. The performance studies are based on mechanical testing, not algorithmic performance.
No
The device is described as an aid to fix fractures during the healing process, providing additional constraint of movement. This indicates a supportive role; it doesn't directly treat or heal the condition itself.
No
This device is a surgical implant designed to aid in the treatment of fractures and osteotomies by providing fixation, not to diagnose a condition.
No
The device description explicitly states it comprises "bone plates, wire forms and screws," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of bone fractures and osteotomies through surgical fixation (plates, screws, wire forms). This is a therapeutic intervention, not a diagnostic one.
- Device Description: The description reinforces the therapeutic nature of the device, stating it's used to "provide additional constraint of movement of a fractured fused or osteotomized bone" and "aid to fix the fracture in place during the healing process."
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.), detect diseases, or provide information for diagnosis.
- Performance Studies: The performance studies mentioned are related to the mechanical properties of the implants (static and dynamic bending), which are relevant for surgical implants, not diagnostic devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for the physical stabilization of bone fractures.
Yes
The letter explicitly states, "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP) titled 'K243987 - Predetermined Change Control Plan - EFS 14MAR2025'".
Intended Use / Indications for Use
The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System:
-
Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used.
-
Fractures and osteotomies of the olecranon.
Product codes (comma separated list FDA assigned to the subject device)
HRS, NDL, NDG, HWC
Device Description
The TriMed® Elbow and Forearm System, comprising of bone plates, wire forms and screws, are intended to be used as an aid to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of plate and/or screw, wire form, tension band, or pin fixation. The TriMed Elbow and Forearm System plates, wire forms and screws are designed to provide additional constraint of movement of a fractured fused or osteotomized bone and are intended only as an aid to fix the fracture in place during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius and ulna, olecranon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
TriMed Elbow and Forearm System 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: Guidance for Industry and Food and Drug Administration Staff.
Static and dynamic four-point bending were conducted per ASTM F382-17.
Clinical studies were not conducted for the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP) titled "K243987 - Predetermined Change Control Plan - EFS 14MAR2025" Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(0) of the Act, respectively.
This submission includes a Predetermined Change Control Plan (PCCP) for TriMed Elbow Forearm System, Olecranon Sled and Washer components. The PCCP establishes a comprehensive framework for managing a pre-planned modification, which includes releasing a design that combines the Olecranon Sled and Washer into a single device. It also details the methods for implementing these modifications. A summary of the proposed modifications, testing methods, and user communication is provided in the table below.
Planned Modifications - Combine the Olecranon Sled and Washer devices into a single device.
Test Methods and Validation Activities - Biocompatibility and Sterilization will be conducted to the same reguirements as set for the TriMed Elbow Forearm System. Construct static bend and endurance bend testing will be performed to verify the mechanical performance for fracture fixation per K243987-Predetermined Change Control Plan-EFS_14MAR2025.
Communication to Users, as Needed - Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device material composition.
§ 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
March 19, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue lettering.
TriMed. Inc. Mikayla German Regulatory Affairs Sr. Specialist 275333 Avenue Hopkins Santa Clarita, California 91355
Re: K243987
Trade/Device Name: TriMed Elbow and Forearm 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, NDL, NDG, HWC Dated: December 10, 2024 Received: December 23, 2024
Dear Mikayla German:
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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP) titled "K243987 - Predetermined Change Control Plan - EFS 14MAR2025" Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device
1
cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(0) of the Act, respectively.
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.
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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-regulatoryassistance/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 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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Indications for Use
Submission Number (if known)
Device Name
TriMed Elbow and Forearm System
Indications for Use (Describe)
The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System:
-
Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used.
-
Fractures and osteotomies of the olecranon.
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: 2025-03-18
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
| Applicant Name | TriMed, Inc. |
|---|---|
| Applicant Address | 275333 Avenue Hopkins Santa Clarita CA 91355 United States |
| Applicant Contact Telephone | 574-767-6560 |
| Applicant Contact | Ms. Mikayla German |
| Applicant Contact Email | mikayla.german@henryschein.com |
21 CFR 807.92(a)(2)
| Device Trade Name | TriMed Elbow and Forearm System |
|---|---|
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification Name | Plate, Fixation, Bone |
| Regulation Number | 888.3030 |
| Product Code(s) | HRS, NDL, NDG, HWC |
21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K060041 | TriMed Bone Plates | HRS |
| K010545 | Tension Band Wire | NDL |
21 CFR 807.92(a)(4)
Device Description Summary
The TriMed® Elbow and Forearm System, comprising of bone plates, wire forms and screws, are intended to be used as an aid to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of plate and/or screw, wire form, tension band, or pin fixation. The TriMed Elbow and Forearm System plates, wire forms and screws are designed to provide additional constraint of movement of a fractured fused or osteotomized bone and are intended only as an aid to fix the fracture in place during the healing
Intended Use/Indications for Use
The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System:
-
Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used.
-
Fractures and osteotomies of the olecranon.
process.
Indications for Use Comparison
The TriMed Elbow and Forearm System has a similar, but if not same, indications for use as the referenced predicate devices.
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Technological Comparison
The implants within the TriMed Elbow and Forearm System ( Plates, Wireforms, Washer, and the predicate devices are manufactured from 316L Stainless Steel. The TriMed Elbow and Fixation System is substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, and labeling, Any differences between the proposed devices and the predicate devices 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 Elbow and Forearm System 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: Guidance for Industry and Food and Drug Administration Staff.
Static and dynamic four-point bending were conducted per ASTM F382-17.
Clinical studies were not conducted for the subject devices.
Based on the indications for use, technological characteristics, and the submitted, TriMed Inc. has deternined that the proposed devices (Bridge plates, 2.7mm locking screws) are substantially equivalent to the currently marketed predicate device.
K243987 - Predetermined Change Control Plan (PCCP) overview is provided below
This submission includes a Predetermined Change Control Plan (PCCP) for TriMed Elbow Forearm System, Olecranon Sled and Washer components. The PCCP establishes a comprehensive framework for managing a pre-planned modification, which includes releasing a design that combines the Olecranon Sled and Washer into a single device. It also details the methods for implementing these modifications. A summary of the proposed modifications, testing methods, and user communication is provided in the table below.
Planned Modifications - Combine the Olecranon Sled and Washer devices into a single device.
Test Methods and Validation Activities - Biocompatibility and Sterilization will be conducted to the same reguirements as set for the TriMed Elbow Forearm System. Construct static bend and endurance bend testing will be performed to verify the mechanical performance for fracture fixation per K243987-Predetermined Change Control Plan-EFS_14MAR2025.
Communication to Users, as Needed - Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device material composition.