(31 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant (threaded intramedullary nail system) for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an intramedullary nail system used to align and stabilize fractures and osteotomies, which falls under fixation devices rather than therapeutic devices that actively treat or heal a condition.
No
The device description clearly states its purpose is for the treatment of fractures and osteotomies, acting as an implantable device to align and stabilize bones. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly states that the TriMed Threaded IM Nail System implants are physical, non-bioabsorbable implantable devices made from metal (Ti-6AL-4V ELI or 316L Stainless steel). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of fractures and corrective osteotomies of short tubular bones. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an implantable medical device used for mechanical fixation of bones. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.
Specific indications for TriMed Small Threaded IM Nails include:
-
Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
-
Metacarpal fractures, non-unions, malunions and corrective osteotomies
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
TriMed Threaded Intramedulary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 12mm and 70mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
short tubular bones, Phalangeal, Metacarpal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The TriMed Threaded IM Nail System implants 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, and per ASTM F543-17:
- Torsional Strength ●
- 0 Driving Torque
- Axial Pullout Strength Calculation ●
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2023
TriMed. Inc. % David Anderson Principle Consultant Tech2Med, LLC 6450 Old Darby TRL NE Ada, Michigan 49301
Re: K230749
Trade/Device Name: TriMed Threaded Intramedullary Nail System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 17, 2023 Received: March 17, 2023
Dear David Anderson:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Shumaya Ali-S
Shumaya Ali, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K230749
Device Name
TriMed Threaded Intramedullary Nail System
Indications for Use (Describe)
The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.
Specific indications for TriMed Small Threaded IM Nails include:
-
Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
-
Metacarpal fractures, non-unions, malunions and corrective osteotomies
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."
3
Image /page/3/Picture/1 description: The image shows the logo for TriMed. The logo consists of a blue symbol that looks like an umbrella with a line through the middle. To the right of the symbol is the word "TriMed" in blue, with a horizontal line underneath.
510(K) SUMMARY
| (a)(1). Submitted By: | TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355
United States of America |
|-------------------------------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | David Anderson
Principle Regulatory Consultant
Office - (574) 377-0111
Fax – (661) 254-8485 |
| Date: | March 17, 2023 |
| (a)(2). Proprietary Name: | TriMed Threaded Intramedullary Nail System |
| Common Name(s): | Screw, Fixation, Bone |
| Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation
fastener |
| Regulatory Class:
Product Codes: | II
HWC |
| (a)(3). Predicate Device: | Primary Predicate
K211783 - Threaded Intramedullary Nail System / TriMed
Inc. (USA) |
(a)(4). Device Description
TriMed Threaded Intramedulary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 12mm and 70mm.
4
Image /page/4/Picture/1 description: The image shows the logo for TriMed. The logo consists of a blue symbol on the left and the word "TriMed" in blue on the right. The symbol is an abstract design, and the word "TriMed" is in a sans-serif font. There is a blue line underneath the word "TriMed".
(a)(5). Indications for Use
The TriMed Threaded IM Nail System is intended for the treatment of select fractures and corrective osteotomies of short tubular bones.
Specific indications for TriMed Small Threaded IM Nails include:
- Phalangeal fractures of the hand. non-unions, malunions and corrective osteotomies 1.
-
- Metacarpal fractures, non-unions, malunions and corrective osteotomies
(a)(6). Technological Characterizes
The subject devices included in The TriMed Threaded IM Nail System are similar to predicate devices in material, size, and have the same indications for use.
(b)(1). Substantial Equivalence: - Non-Clinical Evidence Performance Data
The TriMed Threaded IM Nail System implants 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, and per ASTM F543-17:
- Torsional Strength ●
- 0 Driving Torque
- Axial Pullout Strength Calculation ●
(b)(2). Substantial Equivalence: - Clinical Evidence
Clinical testing was not necessary for the determination of substantial equivalence.
(b)(3). Substantial Equivalence - Conclusions
TriMed Threaded IM Nail System nails, surgical instrument, and tray designs do not adversely affect product performance, cleanability, and sterilization and therefore do not raise any new concerns of safety and efficacy. The similar technological characteristics, indications for use and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.