(66 days)
Not Found
No
The summary describes a mechanical fixation device (plates and screws) and mentions engineering analysis for bending strength comparison, with no indication of software, image processing, or AI/ML components.
Yes
The device is described as providing "fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle" and "total immobilization of the clavicle," which are therapeutic actions aimed at treating a medical condition.
No
The device is described as a fixation plate and screws for treating clavicle fractures, mal-unions, non-unions, and osteotomies. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is comprised of physical plates and screws intended for surgical implantation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the TriMed Clavicle Fixation Plates and Screws are used for the fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle. This is a surgical implant used to stabilize bone, not a device that analyzes biological samples.
- Intended Use: The intended use is directly related to surgical intervention and bone repair, not diagnostic testing.
Therefore, based on the provided information, the TriMed Clavicle Fixation Plates and Screws are a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The TriMed Clavicle Fixation Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
Product codes
HRS, HWC
Device Description
The TriMed Clavicle Fixation Plates are designed to provide total immobilization of the clavicle. The plates utilize 2.7mm and 3.2mm locking cortical screw to secure the plates to the bone. All plates and screws are similar to predicate devices. The TriMed Clavicle Fixation Plates are available in a variety of shapes and sizes to provide superior and anterior fixation of the clavicle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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)
An engineering analysis has been conducted to compare the bending strength of the TriMed Clavicle Fixation Plates to predicate devices to provide justification of the safety and effectiveness of the TriMed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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)
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.
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510(k) Summary of Safety and Effectiveness
TRIMED CLAVICLE FIXATION PLATES
| Submitted/Distributed By: | TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355
(800)633-7221 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 2031009 |
| Prepared By/Contact Person: | Doug Steinberger
Phone: (661)255-7406
Fax: (661)254-8485 |
| Proprietary Name: | TriMed Clavicle Fixation System |
| Classification: | Class II: Screw, Fixation, Bone
HWC - Section 888.3040
Class II: Plate, Fixation, Bone
HRS - Section 888.3030 |
| Summary Preparation Date: | August 24, 2011 |
l. Indications for Use:
The TriMed Clavicle Fixation Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
II. Device Description
The TriMed Clavicle Fixation Plates are designed to provide total immobilization of the clavicle. The plates utilize 2.7mm and 3.2mm locking cortical screw to secure the plates to the bone. All plates and screws are similar to predicate devices. The TriMed Clavicle Fixation Plates are available in a variety of shapes and sizes to provide superior and anterior fixation of the clavicle.
111. Substantial Equivalence Discussion
When compared to the predicate devices listed below, substantial equivalence is based upon similarities in design features and overall indications for use.
| 510(k) Number | Device Name or System | Manufacturer |
|---|---|---|
| K100944 | Clavicle Locking Plating | |
| System | NewClip | |
| K012655 | Congruent Bone Plate System | Acumed |
An engineering analysis has been conducted to compare the bending strength of the TriMed Clavicle Fixation Plates to predicate devices to provide justification of the safety and effectiveness of the TriMed devices.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
TriMed Inc. % Doug Steinberger 27533 Avenue Hopkins Santa Clarita CA 91355
Re: Ki12509
Trade/Device Name: TriMed Clavicle Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 24th, 2011 Received: August 30th, 2011
Dear Mr. Steinberger:
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 (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. 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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): unknown
Clavicle Fixation System Plates and Screws Device Name: Indications For Use:
The Clavicle Fixation System Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
ਮ Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Conqurrence of CDRH, Office of Device Evaluation (ODE)
Richard Oves to MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112501
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