(269 days)
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, calcaneous, fibula and other small bones.
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, calcaneous, femur and fibula.
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 70mm in length.
This document is a 510(k) summary for the TDM Plate and Screw System. It does not describe a study involving an AI/CADeX device or human readers. The acceptance criteria and the study to prove the device meets those criteria are entirely focused on mechanical and material properties of the bone plates and screws.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study/Test Method) | Reported Device Performance |
|---|---|
| ASTM F382-14: "Standard Specification and Test Method for Metallic Bone Plates" | The mechanical test data demonstrates that the TDM Plate and Screw System is adequate for its intended use. |
| 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 | LAL bacterial endotoxin testing was conducted. (Implied to meet acceptance if deemed safe.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested). The provenance of this test data would be the testing facility that performed the ASTM standards and LAL testing, likely a laboratory associated with TDM Co. Ltd. or a contracted testing service. This testing is inherently prospective in nature, as it's performed specifically to demonstrate compliance for regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a mechanical implant, not an AI/CADeX device requiring expert interpretation of images to establish ground truth. The "ground truth" for this device is based on established engineering standards for strength, durability, and biocompatibility.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The TDM Plate and Screw System is a physical implant for bone fixation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical bone plate and screw system, not an algorithm or AI product.
7. Type of Ground Truth Used
The ground truth used for this device's acceptance is based on adherence to established engineering standards (ASTM F382-14 and ASTM F543-13) and biocompatibility testing (LAL bacterial endotoxin testing). These standards define the acceptable mechanical properties and safety profiles for such medical devices.
8. Sample Size for the Training Set
This is not applicable. The TDM Plate and Screw System is a manufactured medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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TDM Co. Ltd. % Babu Periasamy Regulatory Affairs Consultant Lince Consulting LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
March 15, 2018
Re: K171808
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: February 5, 2018 Received: February 6, 2018
Dear Babu Periasamy:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K171808
Device Name TDM Plate and Screw System
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, calcaneous, fibula and other small bones.
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, calcaneous, femur 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 | June 16, 2017 |
|---|---|
| APPLICANT | TDM Co. Ltd.#F105-1.101-104, Sangsan-dong,333,Cheonmdangwagi-ro, Buk-gu, Gwangju, 61008,Republic of KoreaPhone: 82-62-602-7460Fax: 82-62-602-7461 |
| OFFICIALCORRESPONDENT | Sevrina CiucciLincé Consulting, LLCPhone: 408-316-4837Email: sciucci@linceconsulting.com |
| ALTERNATE CONTACT | Nancy LincéLincé Consulting, LLCPhone: 650-759-6186Email: nlince@linceconsulting.com |
| TRADE NAME | TDM Plate and Screw System |
| COMMON NAME | Bone Fixation, Plates and Screws |
| PRODUCT CODE(S); CFRCLASSIFICATION ANDNAME | HRS, HWC21 CFR§888.3030 Single/multiple component metallic bonefixation appliances and accessories21 CFR§888.3040 Smooth or threaded metallic bone fixationFastener |
| PREDICATE DEVICE(S) | Arthrex Fracture Plates (K123241 (subsequently cleared underK141478 & K151732)Arthrex Ankle Fusion Plating System (K141735)Biomet A.L.P.S Calcaneal Plating System (K132898)Hand Innovations Distal Radius Fracture Repair Kit (K030198)Synthes Calcaneal Plate (K020401)Synthes (USA) Clavicle Hook Plate (K061753)Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) |
| DEVICE DESCRIPTION | The TDM Plates and Screw System consists of a family of flat andcontoured plates and screws that make up the Mini and MidLocking Plate and Screw System and the Small Locking Plate andScrew System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety ofconfigurations. 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 70mm in length. | |
| 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, calcaneous, fibula and other small bones. | |
| 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, calcaneous, femur and fibula. | |
| SUBSTANTIALEQUIVALENCE SUMMARY | The TDM Plate and Screw System is substantially equivalent to the predicate devices. The basic design features and intended 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 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. |
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§ 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.