TDM Plate and Screw System

K241128 · Tdm Co., Ltd. · HRS · Dec 5, 2024 · Orthopedic

Device Facts

• Record ID: K241128
• Device Name: TDM Plate and Screw System
• Applicant: Tdm Co., Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 5, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, nonunions, and malunions of bones appropriate for the size of the device. Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. The TDM Screws (1.5mm and larger, Solid and Cannulated) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

Device Story

System of flat and contoured metallic plates and screws for internal bone fixation; used for fractures, fusions, osteotomies, nonunions, and malunions. Operated by orthopedic surgeons in clinical/surgical settings. Plates and screws provide mechanical stabilization of bone segments to facilitate healing. Device selection based on anatomical site and bone size. Benefits include restoration of skeletal alignment and structural support during the bone healing process.

Clinical Evidence

Bench testing only. Performance evaluated via static 4-point bending, axial pullout, and torsional testing in accordance with ASTM F543-17 and ASTM F1264-16 standards. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti). Components: Flat/contoured plates, locking/non-locking screws, cannulated screws (1.5mm-4.0mm diameter, 6mm-100mm length). Standards: ASTM F543-17 (screws), ASTM F1264-16 (plates). Mechanical fixation principle.

Indications for Use

Indicated for patients requiring internal bone fixation for fractures, fusions, osteotomies, nonunions, and malunions of the hands, wrists, feet, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

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

• TDM Plate and Screw Systems (K190391)
• TDM Plate and Screw Systems (K171808)

Submission Summary (Full Text)

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December 5, 2024

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TDM Co., Ltd. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Dr Collegeville, Pennsylvania 19426

Re: K241128

Trade/Device Name: TDM Plate and Screw 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: April 23, 2024 Received: April 24, 2024

Dear Jeena Mathai:

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.

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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 (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 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.

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 Rule"). 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.

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-regulatory

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assistance/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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

K241128

Device Name

TDM Plate and Screw System

Indications for Use (Describe)

The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, nonunions, and malunions of bones appropriate for the size of the device.

Mini and Mid Locking Plate and Screw System:

The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:

The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Screws (1.5mm and larger, Solid and Cannulated) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

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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## K241128 510(k) SUMMARY

## TDM Plate and Screw Systems

| Sponsor: | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | TDM Co. Ltd. 69, Cheomdan Venture So-ro, 37 beon-gil, Buk-gu Gwangju, 61003, Republic of Korea |
| Official Contact Phone: | Jungwook Choi [phone] |
| Fax: | [phone] |
| Contact Person | Jeena Mathai Eerkie Corporation [e-mail] |
| Date: | November 19, 2024 |
| Device Name: | Bone Fixation, Plates and Screws |
| Common Name: | Plate, Fixation, Bone and Screw, Fixation, Bone (Primary) TDM Plate and Screw Systems |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener |
| Classification Number: | 21 CFR 888.3030 (Primary): Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3040 : Smooth or threaded metallic bone fixation fastener Class II |
| Product Code/Classification: | HRS (Primary), HWC class II |
| Description: | The TDM Plate and Screw system consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with locking and non-locking screws and non-locking low profile Screws. The Screw are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 1.5mm to 4.0 in diameter and range from 6mm to 100 in length. |

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| Indications For Use: | The TDM Plate and Screw Systems are indicated for fixation of<br>fractures, fusions, osteotomies, non-unions, and malunions of bones<br>appropriate for the size of the device. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mini and Mid Locking Plate and Screw System:<br>The Mini and Mid Locking Plate and Screw System is intended to be<br>used in the hands, wrist, and small bones in the foot. |
| | Small Locking Plate and Screw System:<br>The Small Locking Plate and Screw System is indicated for the<br>clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. |
| | The TDM Screws (1.5mm and larger, Solid and Cannulated) are<br>intended to be used with the plate for internal bone fixation for bone<br>fractures, fusions, osteotomies and non-unions in the foot, hand,<br>wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and<br>fibula. |
| Performance Data: | The following testing was performed in accordance with the ASTM<br>F543-17 and ASTM F1264-16:<br>- Static 4-Point Bending<br>- Axial Pullout<br>- Torsional<br>The nonclinical tests and engineering analysis demonstrate that<br>the TDM Plate and Screw Systems is as safe, as effective, and is<br>substantially equivalent to the legally marketed predicate device. |
| Predicate Device: | Primary predicate: TDM Co. Ltd. – TDM Plate and Screw Systems<br>(K190391).<br>Additional predicate: TDM Co. Ltd. – TDM Plate and Screw Systems<br>(K171808). |
| Technological Characteristics | The TDM Plate and Screw Systems was shown to be substantially<br>equivalent and has equivalent technological characteristics to its<br>predicate device through comparison in areas including design,<br>labeling/intended use, material composition, function, range of sizes,<br>and packaging. |
| Performance and SE Determination: | The TDM Plate and Screw Systems has been demonstrated to be<br>substantially equivalent to the predicate system(s) with respect to<br>technical characteristics, performance, and intended use. The<br>information provided within this premarket notification supports<br>substantial equivalence of the subject device to the predicate<br>device(s). |