(55 days)
No
The 510(k) summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the treatment of various medical conditions of the cervical spine, providing stabilization as an adjunct to fusion. This indicates a therapeutic function.
No
The device description clearly states it is an "Anterior Cervical Plate System" used for "anterior fixation of the cervical spine... to provide stabilization... as an adjunct to fusion". It consists of physical implants (plates and screws) and instruments for implantation, which are therapeutic interventions, not diagnostic tools.
No
The device description explicitly states it consists of cervical plates, screws, and instruments, all of which are hardware components.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The TDM Anterior Cervical Plate System is a surgical implant used for anterior fixation of the cervical spine. It is a physical device implanted into the body to provide structural support and stabilization.
- No Mention of Samples or Testing: The description focuses on the physical components of the system (plates, screws, instruments) and its surgical application. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the TDM Anterior Cervical Plate System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TDM Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to C7). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The TDM Anterior Cervical Plate System consists of cervical plates, screws and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6AL-4V). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to C7)
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)
Non-clinical testing was performed to demonstrate that the subject TDM Anterior Cervical Plate System is substantially equivalent to the predicate device. The following testing was performed in accordance with ASTM F1717:
- Static compression
- Dynamic compression
- Static Torsion
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Spine - Synthes Anterior CSLP System (K000742)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
April 8, 2024
TDM Co., Ltd. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Dr Collegeville, Pennsylvania 19426
Re: K240423
Trade/Device Name: TDM Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 9, 2024 Received: February 13, 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.
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 OS 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.
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,
Colin
O'neill -S FDA
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240423
Device Name TDM Anterior Cervical Plate System
Indications for Use (Describe)
The TDM Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to C7). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment ve disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
| 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) |
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3
510(k) SUMMARY
TDM's TDM Anterior Cervical Plate System
| Sponsor: | TDM Co. Ltd. |
|---|---|
| Manufacturer | 69, Cheomdan Venture So-ro, 37 beon-gil, Buk-gu Gwangju, 61003, Republic of Korea |
| Official Contact | Jungwook Choi |
| Phone: | +82-62-971-7460 |
| Fax: | +82-62-971-7461 |
| Contact Person | Jeena Mathai |
| mgsharemg@gmail.com | |
| Date: | March 30, 2024 |
| Device Name: | TDM Anterior Cervical Plate System |
| Common Name: | Anterior Cervical Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Number: | 21 CFR 888.3060 |
| Product Code/Classification: | KWQ, class II |
| Description: | The TDM Anterior Cervical Plate System consists of cervical plates, screws and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6AL-4V). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable. |
| Indications For Use: | The TDM Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to C7). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or |
4
| | curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor,
pseudoarthrosis, and failed previous fusion. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Non-clinical testing was performed to demonstrate that the
subject TDM Anterior Cervical Plate System is substantially
equivalent to the predicate device. The following testing was
performed in accordance with ASTM F1717:
- Static compression
- Dynamic compression
- Static Torsion |
| Primary Predicate
Device: | Synthes Spine - Synthes Anterior CSLP System (K000742) |
| Reference Devices: | K171808 & K190391 - TDM Plate and Screw System |
| Technological
Characteristics: | The TDM Anterior Cervical Plate System has substantially equivalent
technological characteristics to its predicate and reference devices
through comparison in areas including design, labeling/intended
use, material composition, function, range of sizes, and packaging. |
| Conclusion: | The TDM Anterior Cervical Plate System 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). |