(101 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
This device is a surgical plating system intended for stabilization of fractures and fusions in the foot; it does not treat or cure a disease but rather provides mechanical support for healing.
No
This device is a surgical plating system intended for the stabilization of fractures and fusion procedures, which are treatments, not diagnostic processes.
No
The device description explicitly states that the system includes plates and screws made from implant grade titanium alloy, which are hardware components.
Based on the provided information, the TriMed ASET™ Foot Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the system is for the "stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet." This describes a surgical implant used to physically support and stabilize bone structures within the body.
- Device Description: The description details plates and screws made from titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The TriMed ASET™ Foot Plating System is an implantable surgical device used within the body.
N/A
Intended Use / Indications for Use
The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:
- · Opening/closing base wedge osteotomies,
- · Distal and proximal chevron osteotomies,
Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- · Primary MTP fusion due to hallux rigidus and/or hallux valgus,
- · Revision MTP fusion,
- · Revision of failed first MTP arthroplasty implant,
Metatarsal and Phalanges:
· Metatarsal and phalanges fractures and osteotomies;
Mid / Hindfoot Fusions:
- · Tarsometatarsal (TMT) fusions/stabilization,
- Intercuneiform fusions.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The TriMed ASET™ Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium alloy. Implant offerings are as followed: 15 MTP fusion plates, Lapidus (With and without hooks) plates, Universal Straight plates, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and nonlocking screws are also included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones of the feet (Forefoot, midfoot and hindfoot)
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 plates were evaluated against the predicate in static and fatigue three-point bend testing. The subject plates were stronger in static bending and equivalent in fatigue bending. The screws were evaluated in ASTM F543 torsional strength testing, insertion/removal torque testing and axial pullout testing. The subject screws were stronger in torsion testing and pullout testing. The insertion torque was equivalent to the predicate and was appropriate compared to the torsional strength.
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
January 5, 2020
Image /page/0/Picture/11 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
TirMed, Inc. David Anderson Principle Consultant Tech2Med, LLC 6450 Old Darby TRL NE Ada, MI 49301
Re: K192696
Trade/Device Name: TriMed ASET Foot Plating 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. HWC Dated: October 10, 2019 Received: October 11, 2019
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, 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
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Indications for Use
510(k) Number (if known) K192696
Device Name The TriMed ASET Foot System
Indications for Use (Describe)
The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:
- · Opening/closing base wedge osteotomies,
- · Distal and proximal chevron osteotomies,
Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- · Primary MTP fusion due to hallux rigidus and/or hallux valgus,
- · Revision MTP fusion,
- · Revision of failed first MTP arthroplasty implant,
Metatarsal and Phalanges:
· Metatarsal and phalanges fractures and osteotomies;
Mid / Hindfoot Fusions:
- · Tarsometatarsal (TMT) fusions/stabilization,
- Intercuneiform fusions.
| 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 in blue. Below the logo is the text "K192696 Page 1 / 2". The logo consists of a stylized symbol and the word "TriMed".
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: | January 2, 2020 |
| (a)(2). Proprietary Name: | TriMed ASET™ Foot Plating System |
| Common Name(s): | Plate, Fixation, Bone |
| Classification Name: | 21 CFR 888.3030: Single/multiple component metallic
bone fixation appliances and accessories |
| Regulatory Class:
Product Codes: | II
HRS, HWC |
| (a)(3). Predicate Device: | K072740: Mondeal Extremity Bone Fixation System, Mondeal
North America, Inc. (Primary)
K152974: The ORTHOLOC® 3Di Foot Reconstruction System,
Wright Medical Technology, Inc. |
(a)(4). Device Description
The TriMed ASET™ Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium alloy. Implant offerings are as followed: 15 MTP fusion plates, Lapidus (With and without hooks) plates, Universal Straight plates, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and nonlocking screws are also included.
4
Image /page/4/Picture/0 description: The image shows the TriMed logo in blue. Below the logo is the text "K192696 Page 2 / 2". The logo consists of a stylized symbol and the word "TriMed" in a sans-serif font.
(a)(5). Indications for Use
- The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:
- · Opening/closing base wedge osteotomies,
- · Distal and proximal chevron osteotomies,
Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP fusion due to hallux rigidus and/or hallux valgus,
- · Revision MTP fusion,
- · Revision of failed first MTP arthroplasty implant,
- Metatarsal and Phalanges:
- Metatarsal and phalanges fractures and osteotomies;
- Mid / Hindfoot Fusions:
- · Tarsometatarsal (TMT) fusions/stabilization,
- · Intercuneiform fusions.
(a)(6). Technological Characterizes
The subject devices included in The TriMed ASET™ Foot Plating System are similar to predicate devices in material, size, and bending strength. The subject plates differ slightly in geometry and may contain hook features.
(b)(1). Substantial Equivalence: - Non-Clinical Evidence
The plates were evaluated against the predicate in static and fatigue three-point bend testing. The subject plates were stronger in static bending and equivalent in fatigue bending. The screws were evaluated in ASTM F543 torsional strength testing, insertion/removal torque testing and axial pullout testing. The subject screws were stronger in torsion testing and pullout testing. The insertion torque was equivalent to the predicate and was appropriate compared to the torsional strength.
(b)(2). Substantial Equivalence: - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
TriMed ASET™ Foot Plating System plate, screw, 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 TriMed ASET™ Foot Plating System with the predicate devices.