(133 days)
Not Found
No
The description focuses on the mechanical components and intended surgical uses of the plating system, with no mention of AI or ML capabilities. Performance studies are based on mechanical testing standards.
Yes
The device is indicated for use in the stabilization of fractures, revision procedures, joint fusions, reconstructions, deformity corrections, osteotomies, and non-unions of small bones of the feet, which are all therapeutic interventions targeting specific medical conditions.
No
This device is a surgical plating system designed for the internal fixation of fractured or damaged bones in the foot. It is used in stabilization and reconstruction procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes "Plates and screws are made from implant grade titanium and titanium alloy," which are physical 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 describes a system for stabilizing fractures, fusions, reconstructions, and osteotomies of bones in the foot. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device consists of plates and screws made from implant-grade materials, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The TriMed ASET™ Foot Plating System is an in vivo device, used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, 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, Ludloff Osteotomy,
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 Fractures: Cuneiform Fracture, Cuboid Fracture, Navicular Fracture
Mid / Hindfoot Fusions:
Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)
Mid / Hindfoot Osteotomies (Deformity Corrections):
Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy
Product codes (comma separated list FDA assigned to the subject device)
HRS
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 and titanium alloy. Implant offerings are as followed: 1st MTP Osteotomy plates, H-Plate, Talonavicular Plate, Calcaneal Slide Osteotomy Plate, Evans Osteotomy Plate, Medial Column Fusion Plate, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and non-locking 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, first metatarsophalangeal joint (MTP), Metatarsal and Phalanges
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 ASET Foot Plating System implants were tested per the recommendations cited in the FDA Guidance Document, Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. Static and dynamic four-point bending were conducted per ASTM F382-17.
The TriMed ASET Calcaneal Sliding Ostected for static bending. Testing showed that loading was greater or equal to the referenced predicate device.
Clinical studies were not conducted for the subject devices.
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
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 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, 2024
TriMed. INC Anderson David Regulatory Affairs Contractor 27533 Avenue Hopkins Valencia, California 91355
Re: K233863
Trade/Device Name: TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-Plate) 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: December 5, 2023 Received: December 6, 2023
Dear Anderson David:
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 (the 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 available 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.
1
K233863 - Anderson David
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate); TriMed ASET Foot Plating System (1st Met Osteotomy Plate); TriMed ASET Foot Plating System (H-Plate); TriMed ASET Foot Plating System (Talonavicular Plate); TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate); TriMed ASET Foot Plating System (Evans Osteotomy Plate); TriMed ASET Foot Plating System (Medial Column Fusion Plate); TriMed ASET Foot Plating System (Straight Plate): TriMed ASET Foot Plating System (T-Plate)
Indications for Use (Describe)
The TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, 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, Ludloff Osteotomy,
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 Fractures: Cuneiform Fracture, Cuboid Fracture, Navicular Fracture
Mid / Hindfoot Fusions:
Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)
Mid / Hindfoot Osteotomies (Deformity Corrections):
Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K233863 |
|---|---|
| 510(k) Summary | |
| Prepared on: 2024-03-19 |
Contact Details
| Applicant Name | TriMed, INC |
|---|---|
| Applicant Address | 27533 Avenue Hopkins Valencia CA 91355 United States |
| Applicant Contact Telephone | (574) 377-0111 |
| Applicant Contact | David Anderson |
| Applicant Contact Email | david.anderson@tech2medllc.com |
Device Name
| Device Trade Name | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate);
TriMed ASET Foot Plating System (1st Met Osteotomy Plate);
TriMed ASET Foot Plating System (H-Plate);
TriMed ASET Foot Plating System (Talonavicular Plate);
TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate);
TriMed ASET Foot Plating System (Evans Osteotomy Plate);
TriMed ASET Foot Plating System (Medial Column Fusion Plate);
TriMed ASET Foot Plating System (Straight Plate);
TriMed ASET Foot Plating System (T-Plate) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification Name | Plate, Fixation, Bone |
| Regulation Number | 888.3030 |
| Product Code | HRS |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K192696 | TriMed ASET Foot Plating System | HRS |
| K222194 | Baby Gorilla/Gorilla Plating System | HRS |
| K072740 | Mondeal Extremity Bone Fixation System | HRS |
Device Description Summary
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 andtomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium and titanium alloy. Implant offerings are as followed: 1st MTP Osteotomy plates, H-Plate, Talonavicular Plate, Calcaneal Slide Osteotomy Plate, Evans Osteotomy Plate, Medial Column Fusion Plate, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and non-locking screws are also included.
Intended Use/Indications for Use
Page 1 of 2
6
The TriMed ASET™ Foot Plating System is indication of fractures, revision procedures, joint fusions, reconstructions, 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, Ludloff Osteotomy,
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 Fractures: Cuneiform Fracture, Cuboid Fracture, Navicular Fracture
Mid / Hindfoot Fusions:
Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathy (Charcot)
Mid / Hindfoot Osteotomies (Deformity Corrections):
Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy
Indications for Use Comparison
The TriMed ASET Foot Plating system has the same Indications for Use as the referenced predicate devices.
Technological Comparison
TriMed ASET Foot Plating System devices are substantially equivalent to the predicate devices in which basic design features, manufacturing, packaging, and labeling are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The TriMed ASET Foot Plating System implants were tested per the recommendations cited in the FDA Guidance Document, Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. Static and dynamic four-point bending were conducted per ASTM F382-17.
The TriMed ASET Calcaneal Sliding Ostected for static bending. Testing showed that loading was greater or equal to the referenced predicate device.
Clinical studies were not conducted for the subject devices.
Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. hat the proposed devices are substantially equivalent to the currently marketed predicate device.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)