(266 days)
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of bone plates and screws, with no mention of AI or ML.
Yes
The device is indicated for the fixation of fractures and ostectomies, and non-unions, which are direct interventions to treat physical conditions, classifying it as a therapeutic device.
No
Explanation: The device is indicated for the fixation of fractures and osteotomies, which is a treatment or therapy, not a diagnostic purpose.
No
The device description explicitly states that the system comprises "a family of flat and contoured plates and screws" constructed from Titanium alloy. This indicates the device is a hardware-based implant system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of fractures and ostectomies of bones (femur and tibia). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a system of plates and screws made of titanium alloy, designed to be implanted to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The TopFix System is indicated for the fixation of fractures and ostectomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).
The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions of the femur and tibia in adult patients with normal or osteopenic bone.
The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).
Product codes
HRS, HWC
Device Description
The TDM Large Bone Plate and Screw System contains the TopFix System, Trifix Large System, and the Newnecks System, which comprise a family of flat and contoured plates and screws. The plates are constructed from Titanium alloy (Ti-6AL-4V) 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, cannulated screws from 4.0mm to 6.5mm in diameter and range from 12mm to 100mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, proximal tibia, femur, tibia, femoral trochanteric region
Indicated Patient Age Range
adult patients
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 properties were tested based on the below referenced standards. The test results support substantial equivalence to the predicate devices.
▪A biocompatibility evaluation for TDM Large Bone Plate and Screw System (subject device) has been conducted. The TDM Large Bone Plate and Screw System is made from Ti6Al4V ELI (ASTM F136) and Pure titanium (ASTM F67), which is the same type of titanium alloy and pure titanium used by the predicate device systems. The assessment results ensures that no additional risks arise from biological hazards associated with materials and, manufacturing methods involved in making the subject device. ▪Performance testing was conducted in conformance to "ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates" and ASTM F543-17 "Standard Specification and Test Methods for Metallic Medical Bone Screws" and leveraged the FDA Guidance documents "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway", "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway".
Bench test results concluded that TDM Large Bone Plate and Screw System is substantially equivalent to the predicate devices for its intended use.
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.
K141796, K112406, K210043, K080522, K202912, K213059, K082624
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.
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
April 5, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Tdm Co., Ltd % Dave Kim Regulatory Affairs Cosultant Mtech Group LLC 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K232115
Trade/Device Name: TDM Large Bone 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: March 8, 2024 Received: March 8, 2024
Dear Dave Kim:
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.
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).
1
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 (OS) 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.
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 mediation-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 -S
Shumaya Ali, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K232115
Device Name
TDM Large Bone Plate and Screw System
Indications for Use (Describe)
The TopFix System is indicated for the fixation of fractures and ostectomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).
The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions of the femur and tibia in adult patients with normal or osteopenic bone.
The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).
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 K232115
The following 510(k) summary is being submitted as required by 21 CFR Part 807.92;
| 5.1 | Submitter information
(21 CFR 807.92(a)(1)) | TDM CO., LTD.
69, Cheomdan Venture So-Ro 37beon-Gil
Gwangju, KR 61003
Tel: +82-62-971-7460
Fax: +82-62-971-7461
Establishment registration number: 301425777 |
|-----|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
(Official Correspondent) | Mr. Dave Kim
7505 Fannin St. Suite 610, Houston, TX 77054
Tel: 713-467-2607 |
Date Prepared: April 3, 2024
Name of the device (21 CFR 807.92(a)(2))
- Trade Name ●
- . TDM Large Bone Plate and Screw System
- Common Name .
- I Plate, Fixation, Bone (Primary)
- Screw, Fixation, Bone
- Classification Name ●
- " Single/multiple component metallic bone fixation appliances and accessories (Primary)
Email: davekim@mtechgroupllc.com
- . Smooth or threaded metallic bone fixation fastener
- Regulation Number
- l 21 CFR 888.3030 (Primary)
- l 21 CFR 888.3040
- Regulatory Class
- Class II
- Product Code
.
5.2
- HRS (primary) "
- ı HWC
Identification of the predicate (21 CFR 807.92(a)(3))
- Primary Predicate Device
- K141796, "DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM", manufactured O by "SYNTHES (USA) PRODUCTS LLC"
- Additional Predicate Devices
- K112406, "PERI-LOC TM Periarticular Lacked Plating System Proximal Femur O Lacking Bone Plate" , manufactured by "Smith & Nephew, Inc."
- K210043, "LOQTEQ® Distal Lateral Femur Plate 4.5 System", manufactured by O "AAP Implantate AG"
- K080522, "Synthes 3.5 mm LCP Distal Tibia T Plates", manufactured by O "Synthes (USA)"
4
- K202912, "ARIX Ankle Distal Tibia System", manufactured by "Jeil Medical O Corporation"
- K213059, "Tibia and Fibula System", manufactured by "Auxein Medical Private O Limited"
- K082624, "Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia O PlatesPlates", manufactured by "Synthes (USA)"
- . Reference Devices
5.3 Description of the device (21 CFR 807.92(a)(4))
The TDM Large Bone Plate and Screw System contains the TopFix System, Trifix Large System, and the Newnecks System, which comprise a family of flat and contoured plates and screws. The plates are constructed from Titanium alloy (Ti-6AL-4V) 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, cannulated screws from 4.0mm to 6.5mm in diameter and range from 12mm to 100mm in length.
Statement of intended use (21 CFR 807.92 (a) (5)) 5.4
The TopFix System is indicated for the fixation of fractures and osteotomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).
The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions, and malunions of the femur and tibia in adult patients with normal or osteopenic bone.
The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).
Summary of technological characteristics (21 CFR 807.92(a)(6)) 5.5
. TopFix System:
The primary predicate device K141796 supports substantial equivalence of the subject Topfix Plates in terms of similar plate designs, similar plate dimensions (i.e., length, width, thickness), similar indications for use (IFU), similar plate materials (Pure Titanium vs Titanium Alloy), sterilization parameters. Comparative mechanical performance testing (per ASTM F382-17) demonstrated greater bending strength and bending structural stiffness compared to the predicate plates (K141796).
The diameters and lengths of the screws for the subject device and the predicate device are similar. They are tested and met the standard specification and test methods as per ASTM F543-17.
Trifix Large System: ●
The Trifix Large System consists of the following plates: the Distal Femur Locking Plate, Lateral, Distal Tibia Locking Plate, Lateral, Distal Tibia Locking Plate, Medial, Proximal Tibia Locking Plate Lateral, and Proximal Tibia Locking Plate Medial.
- The Distal Femur Locking Plate, Lateral has similar plate material, similar . indications for use, plate designs, dimensions, and shape compared to K210043. These plates were evaluated by 4-Point Bend Testing per ASTM F382-17 and found to be substantially equivalent by meeting the mechanical performance criteria set by the FDA Guidance 'Orthopedic Fracture Fixation Plates
- Performance Criteria for Safety and Performance Based Pathway'.
5
- The Distal Tibia Locking Plate, Lateral is similar compared to K080522 in terms of . indications for use, plate materials (Titanium Alloy vs Titanium) and design (length, width, shape, thickness). Its mechanical performance demonstrates SE. The plates were evaluated by 4-Point Bend Testing per ASTM F382-17 and found to be substantially equivalent by meeting the mechanical performance criteria set by the FDA Guidance 'Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway'.
- . The Distal Tibia Locking Plate, Medial has similar indications for use, plate materials compared to K202912. The plate design and dimension are similar to K202912 demonstrating substantial equivalence. The plates were evaluated by 4-Point Bend Testing per ASTM F382-17 and found to be substantially equivalent by meeting the mechanical performance criteria set by the FDA Guidance 'Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway'.
- The Proximal Tibia Locking Plate Lateral has similar indications for use and plate . materials compared to K213059. The plate design and dimension are similar to K213059 demonstrating substantial equivalence. The plates were evaluated by 4-Point Bend Testing per ASTM F382-17 and found to be substantially equivalent by meeting the mechanical performance criteria set by the FDA Guidance 'Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway'.
- . The Proximal Tibia Locking Plate Medial compared to K082624 has similar indications and plate materials. The plate design and dimension are similar to K082624 demonstrating substantial equivalence. The plates were evaluated by 4-Point Bend Testing per ASTM F382-17 and found to be substantially equivalent by meeting the mechanical performance criteria set by the FDA Guidance 'Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway'.
Newnecks System: .
The Newnecks System consists of the Newnecks plates. The Newnecks plates have similar indications for use and plate materials compared to K112406. The plate design and dimensions are similar to K112406 demonstrating substantial equivalence. These plates were evaluated by 4-Point Bend Testing per ASTM F382-17 and found to be substantially equivalent by meeting the mechanical performance criteria set by the FDA Guidance 'Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway'.
5.6 Brief discussion of non-clinical tests (21 CFR 8070.92(b)(1))
The following properties were tested based on the below referenced standards. The test results support substantial equivalence to the predicate devices.
▪A biocompatibility evaluation for TDM Large Bone Plate and Screw System (subject device) has been conducted. The TDM Large Bone Plate and Screw System is made from Ti6Al4V ELI (ASTM F136) and Pure titanium (ASTM F67), which is the same type of titanium alloy and pure titanium used by the predicate device systems. The assessment results ensures that no additional risks arise from biological hazards associated with materials and, manufacturing methods involved in making the subject device. ▪Performance testing was conducted in conformance to "ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates" and ASTM F543-17 "Standard Specification and Test Methods for Metallic Medical Bone Screws" and leveraged the FDA Guidance documents "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway",
6
"Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway".
Bench test results concluded that TDM Large Bone Plate and Screw System is substantially equivalent to the predicate devices for its intended use.
5.7 Discussion of clinical tests (21 CFR 807.92(b)(2))
Clinical testing was not required for this submission.
5.8 Conclusion from nonclinical and clinical tests (21 CFR 807.92(a)(3))
The TDM Large Bone Plate and Screw System is substantially equivalent to Predicate Devices. The following comparison table is presented to demonstrate substantial equivalence.
The TDM Large Bone Plate and Screw System does not have a new intended use. It shows equivalent specifications with the predicate devices in most of the parameters. Also, there are no significant differences in some parameters between the TDM Large Bone Plate and Screw System and Predicate Devices.
The TDM Large Bone Plate and Screw System and Predicate Devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
Based on the testing results, TDM CO., LTD. concludes that the subject device is substantially equivalent to the predicate device