TriMed Bridge Plates

K241942 · TriMed, Inc. · HRS · Sep 17, 2024 · Orthopedic

Device Facts

• Record ID: K241942
• Device Name: TriMed Bridge Plates
• Applicant: TriMed, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TriMed Bridge Plate is indicated for fixation of fractures, osteotomies, and nonunions of the radius.

Device Story

TriMed Bridge Plates are temporary joint-spanning metallic plates used for fixation of radius fractures, osteotomies, and nonunions. Manufactured from medical-grade 316L stainless steel, these plates are designed for use with 2.7mm and 3.2mm locking and non-locking screws. The device is distributed as part of the TriMed Wrist Fixation System 3. It is intended for use by orthopedic surgeons in a clinical or surgical setting to stabilize bone segments, facilitating healing and restoring structural integrity. The surgeon selects and applies the plate to the bone site to provide mechanical support during the fracture healing process.

Clinical Evidence

No clinical studies were conducted. Evidence is based on bench testing, including static and dynamic four-point bending tests performed in accordance with ASTM F382-17 and the FDA guidance document 'Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway'.

Technological Characteristics

Material: 316L stainless steel. Compatibility: 2.7mm and 3.2mm locking and non-locking screws. Testing standards: ASTM F382-17 (static and dynamic four-point bending). Form factor: Joint-spanning bone fixation plate.

Indications for Use

Indicated for fixation of fractures, osteotomies, and nonunions of the radius in patients requiring bone fixation.

Regulatory Classification

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.

Predicate Devices

• Acumed Wrist Spanning Plate (K131764)

Reference Devices

• TriMed Wrist Fixation System 3 (K222637)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 17, 2024

TriMed, Inc. Divya Raghavi Nandakumar Regulatory Affairs Supervisor 27533 Avenue Hopkins Santa Clarita, California 91355

Re: K241942

Trade/Device Name: TriMed Bridge Plates 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: July 1, 2024 Received: July 2, 2024

Dear Divya Raghavi Nandakumar:

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.

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"

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(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 (QS) 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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Christopher Ferreira -S

Christopher Ferreira. M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241942

Device Name

TriMed Bridge Plates

Indications for Use (Describe)

TriMed Bridge Plate is indicated for fixation of fractures, and nonunions of the radius.

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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| 510(k) #: | K241942 | 510(k) Summary | Prepared on: | 2024-09-11 |
|-----------|---------|----------------|--------------|------------|
|-----------|---------|----------------|--------------|------------|

| Contact Details | 21 CFR 807.92(a)(1) |
|-----------------------------|-----------------------------------------------------------|
| Applicant Name | TriMed, Inc. |
| Applicant Address | 27533 Avenue Hopkins Santa Clarita CA 91355 United States |
| Applicant Contact Telephone | [phone] |
| Applicant Contact | Mrs. Divya Raghavi Nandakumar |
| Applicant Contact Email | [e-mail] |

| Device Name | 21 CFR 807.92(a)(2) |
|---------------------|---------------------------------------------------------------------------------------|
| Device Trade Name | TriMed Bridge Plates |
| Common Name | Plate, Fixation, Bone (primary) |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories (primary) |
| Regulation Number | 888.3030 (primary), 888.3040 |
| Product Code(s) | HRS (primary), HWC |

| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|------------------------------------|---------------------|
|------------------------------------|---------------------|

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K131764 | Acumed Wrist Spanning Plate | HRS |

| Device Description Summary | 21 CFR 807.92(a)(4) |
|----------------------------|---------------------|
|----------------------------|---------------------|

TriMed Bridge plates are temporary joint spanning plates are indicated to be used as an aid to the treatment of fractures, osteotomies and non-unions of the radius. TriMed Bridge plates are manufactured from medical grade stainless steel. There plates are compatible with 2.7mm and 3.2mm locking and non-locking screws. Devices included in this application will be distributed as part of the TriMed Wrist Fivation Sustom 3 cleared under K222637.

| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|----------------------------------|---------------------|
|----------------------------------|---------------------|

TriMed Bridge Plate is indicated for fixation of fractures, osteotomies, and nonunions of the radius.

| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
|--------------------------------|---------------------|
|--------------------------------|---------------------|

TriMed Bridge Plate has the same Indications for Use as the referenced predicate device.

| Technological Comparison | 21 CFR 807.92(a)(6) |
|--------------------------|---------------------|
|--------------------------|---------------------|

TriMed Bridge Plate is manufactured from 316L Stainless Steel, whereas the predicate device is manufactured from titanium alloy. TriMed Bridge Plate is substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling. 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) |
|----------------------------------------------------------|------------------|
|----------------------------------------------------------|------------------|

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TriMed Bridge Plates were tested per the recomment, on 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. Stafic and dynamic four-point bending were conducted per ASTM F382-17.

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 (Bridge plates, 2.7mm locking screws) are substantially equivalent to the currently marketed predicate device.