(269 days)
Not Found
No
The summary describes a system of bone plates and screws, which are mechanical implants. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a system of plates and screws used for internal bone fixation of fractures, fusions, osteotomies, and non-unions, which are all therapeutic interventions for the human body.
No
Explanation: The device is a system of plates and screws used for internal bone fixation (e.g., for fractures, fusions). Its stated "Intended Use / Indications for Use" describes therapeutic applications, not diagnostic ones. There is no mention of it being used to detect, monitor, or identify a medical condition.
No
The device description explicitly states that the device consists of physical plates and screws made from Titanium alloy and pure Titanium. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Locking Plate and Screw System" for internal bone fixation in various anatomical sites (hands, wrist, foot, clavicle, etc.). This is a surgical implant used to stabilize bone fractures, fusions, osteotomies, and non-unions.
- Device Description: The description details the physical components (plates and screws made of titanium alloy) and their function in bone fixation.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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) 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 Plates 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 solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, from 1.5mm to 4.0mm in diameter and range from 6mm to 100mm in lenath.
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, and fibula.
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)
Performance testing was performed in accordance with ASTM F382-14, "Standard Specification and Test Method for Metallic Bone Plates" and ASTM F543-13, "Standard Specification and Test Methods for Metallic Medical Bone Screws". The mechanical test data demonstrates that the TDM Plate and Screw System is adequate for its intended use. LAL bacterial endotoxin testing was conducted. Clinical data was not needed for this 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.
K171808 TDM Plate and Screw System, K030310 Synthes Stainless Steel Modular Hand System, K050110 Synthes (USA) LCP Modular Foot Plates, K060514 Stryker Plating System, K061753 Synthes (USA) Clavicle Hook Plate, K063049 Synthes (USA) Modular Mini Fragment LCP System, K073186 Synthes 3.5mm LCP Clavicle Plate System, K082807 Synthes (USA) 3.5mm and 4.5mm Locking Compression Plate (LCP) System with Expanded Indications, K083213 Synthes 2.7 mm and 3.5 mm LCP Distal Fibula Plates - Modifications, K090047 Synthes (USA) 1.5mm Mini Fragment LCP System
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 logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.
November 15, 2019
TDM Co. Ltd. % Sevrina Ciucci Regulatory Consultant Lince Consulting LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K190391
Trade/Device Name: TDM Plate and Screw Systems 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 16, 2019 Received: October 17, 2019
Dear Sevrina Ciucci:
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.
1
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 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) K190391
Device Name TDM Plate and Screw Systems
Indications for Use (Describe)
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) 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| DATE PREPARED | November 15, 2019 |
|---|---|
| APPLICANT | TDM Co. Ltd. |
| 69, Cheomdan Venture So-ro, 37 beon-gil, | |
| Buk-gu, Gwangju, 61003 | |
| Republic of Korea | |
| Phone: 82-62-971-7460 | |
| Fax: 82-62-971-7461 | |
| Establishment Registration No.: 3014257776 | |
| OFFICIAL | |
| CORRESPONDENT | Sevrina Ciucci |
| Lincé Consulting, LLC | |
| Phone: 408-316-4837 | |
| Email: sciucci@linceconsulting.com | |
| ALTERNATE CONTACT | Nancy Lincé |
| Lincé Consulting, LLC | |
| Phone: 650-759-6186 | |
| Email: nlince@linceconsulting.com | |
| TRADE NAME | TDM Plate and Screw Systems |
| COMMON NAME | Bone Fixation, Plates and Screws |
| PRODUCT CODE(S); CFR | |
| CLASSIFICATION AND | |
| NAME | HRS, HWC |
| 21 CFR§888.3030 Single/multiple component metallic bone | |
| fixation appliances and accessories | |
| 21 CFR§888.3040 Smooth or threaded metallic bone fixation | |
| Fastener | |
| PRIMARY PREDICATE | |
| DEVICE | K171808 TDM Plate and Screw System |
| ADDITIONAL PREDICATE | |
| DEVICES | K030310 Synthes Stainless Steel Modular Hand System |
| K050110 Synthes (USA) LCP Modular Foot Plates | |
| K060514 Stryker Plating System | |
| K061753 Synthes (USA) Clavicle Hook Plate | |
| K063049 Synthes (USA) Modular Mini Fragment LCP System | |
| K073186 Synthes 3.5mm LCP Clavicle Plate System | |
| K082807 Synthes (USA) 3.5mm and 4.5mm Locking | |
| Compression Plate (LCP) System with Expanded Indications | |
| K083213 Synthes 2.7 mm and 3.5 mm LCP Distal Fibula Plates |
- Modifications
K090047 Synthes (USA) 1.5mm Mini Fragment LCP System |
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K102694 Synthes 2.4mm Variable Angle LCP Dorsal Distal Radius Plates K120689 Synthes 3.5 mm VA-LCP Proximal Tibia Plate System K120854 Synthes Variable Angle LCP Ankle Trauma System K141735 Arthrex Ankle Fusion Plating System K150099 DePuv Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) K163293 In2Bones Colink Plating System K180310 DePuy Synthes Trauma Orthopedic Plates and Screws DEVICE DESCRIPTION The TDM Plates 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 solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, from 1.5mm to 4.0mm in diameter and range from 6mm to 100mm in lenath. INTENDED USE 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) 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. SUBSTANTIAL The TDM Plate and Screw System is substantially equivalent to the predicate devices. The basic design features and intended EQUIVALENCE SUMMARY uses are the same. Any differences between the TDM Plate and Screw System and the predicates are considered minor and do not raise questions concerning safety and effectiveness. The proposed devices are substantially equivalent to the predicate devices in regards to intended use, design, and materials. Performance testing was performed in accordance with ASTM F382-14, "Standard Specification and Test Method for Metallic Bone Plates" and ASTM F543-13, "Standard Specification and Test Methods for Metallic Medical Bone Screws". The mechanical test data demonstrates that the TDM Plate and Screw System is
5
adequate for its intended use. LAL bacterial endotoxin testing was conducted. Clinical data was not needed for this device.
Based on the indications for use, technological characteristics, and comparison to the predicate device, the TDM Plate and Screw System is determined to be substantially equivalent to currently marketed predicate devices.