(58 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of the intramedullary nail system, with no mention of AI or ML.
No.
The device is a non-bioabsorbable implantable device intended to aid in the treatment of fractures and osteotomies by providing alignment and stabilization. It does not actively heal or treat but provides support for the body's natural healing processes.
No
This device is an implant used for the treatment of fractures and osteotomies of short tubular bones, not for diagnosing medical conditions.
No
The device description clearly states it is an implantable device made of metallic materials (Ti-6AL-4V ELI or 316L Stainless steel) and describes physical dimensions (diameters and lengths), indicating 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the TriMed Threaded IM Nail System is an implantable device used for the treatment of fractures and corrective osteotomies of bones. It is a physical device inserted into the body to stabilize and align bone fragments.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
The device is a surgical implant used for orthopedic procedures, not a diagnostic tool.
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 Intramedullary (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 20mm 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 fractures of the hand, Metacarpal fractures
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)
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
- 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
August 6, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services 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.
TriMed, Inc. % David Anderson Principle Consultant Tech2Med, LLC 6450 Old Darby TRL NE Ada, Michigan 49301
Re: K211783
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: June 4, 2021 Received: June 9, 2021
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.
1
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 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, MPH 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)
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) |
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3
Image /page/3/Picture/0 description: The image shows the TriMed logo, which consists of a blue symbol resembling an umbrella or a stylized 'T', along with the text 'TriMed' in a matching blue font. Below the logo, there is a line of text that reads 'K211783 - Page 1 / 2'. This text appears to be a document identifier and page number.
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: | August 6, 2021 |
| (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
K192745 - Depuy Synthes Trauma Screws, Synthes (USA)
Products LLC / DePuy Orthopaedics Inc. (Primary)
Other Predicate Device(s)
K170021 – SMV Scientific Cannulated Compression Screws,
SMV Scientific
K202589 – APTUS Cannulated Compression Screws, Medart
AG |
(a)(4). Device Description
TriMed Threaded Intramedullary (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 20mm and 70mm.
4
Image /page/4/Picture/0 description: The image shows the TriMed logo, which consists of a blue symbol and the word "TriMed" in blue. Below the logo is the text "K211783 - Page 2 / 2". The logo is simple and clean, with the text providing context for the document.
(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
-
- 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
- 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.