(269 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of bone plates and screws, with no mention of AI or ML.
Yes
This device is a plate and screw system intended for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions, which are therapeutic interventions.
No.
The device is a system of plates and screws intended for internal bone fixation for fractures, fusions, osteotomies, and non-unions, which means it is a therapeutic device rather than a diagnostic one.
No
The device description explicitly states that the system consists of physical plates and screws made from titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in various anatomical locations. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as plates and screws made of titanium alloy, designed for surgical implantation.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device described is a surgical implant used for orthopedic procedures.
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, 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.
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 70mm 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, calcaneous, fibula, femur
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.
K123241, K141478, K151732, K141735, K132898, K030198, K020401, K061753, K090047
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with a stylized image of three faces in profile, representing the Department of Health & Human Services. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 Korea | |
| Phone: 82-62-602-7460 | |
| Fax: 82-62-602-7461 | |
| 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 System |
| 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 |
| PREDICATE DEVICE(S) | Arthrex Fracture Plates (K123241 (subsequently cleared under
K141478 & 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 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. |
| 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. |
| SUBSTANTIAL
EQUIVALENCE 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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