(326 days)
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML, image processing, or data-driven analysis.
Yes
The device is described as supporting "wrist arthrodesis and fixation of fractures," which directly addresses a medical condition or ailment, indicating a therapeutic purpose.
No
Explanation: The device is described as a system of plates and screws for wrist fusion and fixation of bone fractures, which are therapeutic and reconstructive purposes, not diagnostic.
No
The device description explicitly states that the system comprises bone plates and screws, which are physical hardware components made of stainless steel or titanium alloy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "wrist arthrodesis and fixation of fractures of other small bones." This describes a surgical procedure and the use of a physical implant, not a test performed on a biological sample outside the body.
- Device Description: The device is described as "bone plates and screws" made of stainless steel or titanium alloy. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a surgical implant used to stabilize bones.
N/A
Intended Use / Indications for Use
The TriMed Radiocarpal Fusion System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
TriMed Radiocarpal Fusion plates are designed to provide total immobilization of the wrist during wrist arthrodesis and for fixation of fractures of other small bones. The TriMed Radiocarpal Fusion System comprises of bone plates and screws. All plates and screws are similar to predicate devices. TriMed Radiocarpal Fusion plates come in a variety of lengths, bend angles, and screw mating configurations. All plates are designed to accommodate locking and non-locking screws. TriMed cortical bone screws for the wrist fusion application are available in diameters of 2.7 mm and 3.2 mm. All screws come in a variety of lengths and plate locking conditions. The Radiocarpal Fusion plates and screws are made of either ASTM F138/139 implant grade stainless steel or ASTM F136 implant grade Titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, small bones
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)
Theoretical calculations and mechanical tests in the form of static bending loads have been performed to verify the safety and functionality of the device. Results demonstrate that the physical properties of the TriMed Radiocarpal Fusion Plating System are substantially equivalent to the predicated devices. The new product does not change the intended use or scientific principles used for safe and effective implantation of the device
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).
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
TriMed.
AUG 1 9 2011
510(K) Summary of Safety and Effectiveness RADIOCARPAL FUSION SYSTEM
| Submitted By: | TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355
(800) 633-7221 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration #: | 2031009 |
| Prepared By: | Doug Steinberger,
QA/RA Manager |
| Proprietary Name: | Radiocarpal Fusion System |
| Classification: | Class II: Plate Fixation, Bone
HRS - Section 888.3030 |
| | Class II: Screw Fixation, Bone
HRS - Section 888.3040 |
| Predicate Devices: | K042355 - Synthes LCP
Wrist Fusion System |
| | K011335 - Synthes One-Third
Tubular DCL Plate |
| Indications for Use: | The TriMed Radiocarpal Fusion System plates and screws are intended for
wrist arthrodesis and fixation of fractures of other small bones. |
| Device Description: | TriMed Radiocarpal Fusion plates are designed to provide total
immobilization of the wrist during wrist arthrodesis and for fixation of
fractures of other small bones.
The TriMed Radiocarpal Fusion System comprises of bone plates and
screws. All plates and screws are similar to predicate devices. TriMed
Radiocarpal Fusion plates come in a variety of lengths, bend angles, and
screw mating configurations. All plates are designed to accommodate
locking and non-locking screws. |
| TriMed cortical bone screws for the wrist fusion application are available in
diameters of 2.7 mm and 3.2 mm. All screws come in a variety of lengths
and plate locking conditions. The Radiocarpal Fusion plates and screws are | |
ADVANCED FIXATION TECHNOLOGIES"
1
102785
Image /page/1/Picture/1 description: The image shows the logo for TriMed. The logo consists of a stylized graphic to the left of the word "TriMed." The graphic is black and appears to be an abstract representation of three interconnected arches. The word "TriMed" is also in black, with a small trademark symbol to the right of the word. A horizontal line runs beneath the graphic and the word.
Preparation Date: July 26, 2011
made of either ASTM F138/139 implant grade stainless steel or ASTM F136 implant grade Titanium alloy.
Substantial Equivalence:
Theoretical calculations and mechanical tests in the form of static bending loads have been performed to verify the safety and functionality of the device. Results demonstrate that the physical properties of the TriMed Radiocarpal Fusion Plating System are substantially equivalent to the predicated devices. The new product does not change the intended use or scientific principles used for safe and effective implantation of the device
p. 2 of 2
ADVANCED FIXATION TECHNOLOGIES™
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TriMed Inc. % Mr. Doug Steinberger QA/RA Manager 28337 Maitland Lane Saugus. California 91350
AUG 1 9 2011
Re: K102785
Trade/Device Name: Radiocarpal Fusion Plate 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 Dated: July 26, 2011 Received: July 27, 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.
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
3
Page 2 - Mr. Doug Steinberger
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/Reportal?roblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric Keith
forMark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
(in mm).
Device Name: Radiocarpal Fusion Plate System
Indications For Use:
The TriMed Radiocarpal Fusion System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones
02785
x Prescription Use AND/OR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102785
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