(225 days)
Not Found
No
The document describes a mechanical implant system (plates and screws) and its intended use and materials. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are mechanical tests.
Yes
The device is described as a system of plates and screws used for fixation of fractures, fusions, osteotomies, non-unions, and malunions, which are all therapeutic interventions.
No
This device is a plate and screw system intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions, which are treatment procedures rather than diagnostic ones.
No
The device description explicitly states that the system consists of physical plates and screws made from Titanium alloy or pure Titanium, which are hardware components.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes the TDM Plate and Screw Systems as implants used for the fixation of bones in various parts of the body (fractures, fusions, osteotomies, etc.). This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for internal bone fixation.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, wrist, small bones in the foot, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, foot
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 following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:
- Static 4-Point Bending
- Axial Pullout
- Torsional
The nonclinical tests and engineering analysis demonstrate that the TDM Plate and Screw Systems is as safe, as effective, and is substantially equivalent to the legally marketed predicate device.
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
December 5, 2024
Image /page/0/Picture/1 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 and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
assistance/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,
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
3
Indications for Use
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 +82-62-971-7460 |
| Fax: | +82-62-971-7461 |
| Contact Person | Jeena Mathai Eerkie Corporation mgsharemg@gmail.com |
| 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. |
5
| Indications For Use: | The TDM Plate and Screw Systems are indicated for fixation of
fractures, fusions, osteotomies, non-unions, 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. |
| Performance Data: | The following testing was performed in accordance with the ASTM
F543-17 and ASTM F1264-16:
- Static 4-Point Bending
- Axial Pullout
- Torsional
The nonclinical tests and engineering analysis demonstrate that
the TDM Plate and Screw Systems is as safe, as effective, and is
substantially equivalent to the legally marketed predicate device. |
| Predicate Device: | Primary predicate: TDM Co. Ltd. – TDM Plate and Screw Systems
(K190391).
Additional predicate: TDM Co. Ltd. – TDM Plate and Screw Systems
(K171808). |
| Technological Characteristics | The TDM Plate and Screw Systems was shown to be substantially
equivalent and has equivalent technological characteristics to its
predicate device through comparison in areas including design,
labeling/intended use, material composition, function, range of sizes,
and packaging. |
| Performance and SE Determination: | The TDM Plate and Screw Systems has been demonstrated to be
substantially equivalent to the predicate system(s) with respect to
technical characteristics, performance, and intended use. The
information provided within this premarket notification supports
substantial equivalence of the subject device to the predicate
device(s). |