(209 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of bone screws, with no mention of AI or ML technology.
Yes
The device is described as an internal bone fixation system for fractures, fusions, osteotomies, non-unions, and malunions, which are all medical conditions requiring therapeutic intervention.
No
This device is a surgical implant (screws) used for fixation of bones, not for diagnosing conditions. Its intended uses involve treatment (fixation of fractures, fusions, etc.), not detection or assessment of medical conditions.
No
The device description explicitly states the device is constructed from Titanium alloy and is comprised of physical components like screws and washers. It is a hardware device for internal bone fixation.
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, fusions, osteotomies, non-unions, and malunions of bones. This is a surgical intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as screws and washers made of titanium alloy, intended for internal bone fixation. This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of the hand or foot or small and large bones.
Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The TDM Screw Systems consist of a family of devices intended for internal bone fixation of fractures, fusions, osteotomies, non unions, and malunions. The subject devices are constructed from Titanium alloy (ASTM F136) and are comprised of cannulated screws, headless compression cannulated screws, limited sliding screws, compression screws, and washers. The subject devices are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging from 10mm to 125mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, hand, foot, wrist, humerus, femur, tibia, proximal 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)
The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:
- Torsional
- Pullout
- 3-Point Bending
The nonclinical tests and engineering analysis demonstrate that the TDM Screw System is as safe, as effective, and is substantially equivalent to the legally marketed predicate 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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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January 18, 2024
Image /page/0/Picture/1 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TDM Co., Ltd. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Dr Collegeville, Pennsylvania 19426
Re: K231860
Trade/Device Name: TDM Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 19, 2023 Received: December 19, 2023
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).
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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 Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231860
Device Name TDM Screw System
Indications for Use (Describe)
The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of the hand or foot or small and large bones.
Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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K231860
510(k) SUMMARY
TDM Screw System
| Sponsor: | Manufacturer TDM Co. Ltd.
69, Cheomdan Venture So-ro, 37 beon-gil, Buk-gu
Gwangju, 61003, Republic of Korea |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact
Phone:
Fax: | Jungwook Choi
+82-62-971-7460
+82-62-971-7461 |
| Contact Person | Jeena Mathai
Eerkie Corporation
mgsharemg@gmail.com |
| Date: | June 21, 2023 |
| Common Name: | Screw, Fixation, Bone
Washer, Bolt Nut |
| Device Name: | TDM Screw System |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (Primary)
Single/multiple component metallic bone fixation appliances and accessories |
| Classification Number: | 21 CFR 888.3040 (Primary)
21 CFR 888.3030 |
| Product
Code/Classification: | HWC (Primary), HTN class II |
| Description: | The TDM Screw Systems consist of a family of devices intended for internal bone
fixation of fractures, fusions, osteotomies, non unions, and malunions. The
subject devices are constructed from Titanium alloy (ASTM F136) and are
comprised of cannulated screws, headless compression cannulated screws,
limited sliding screws, compression screws, and washers. The subject devices
are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging
from 10mm to 125mm. The Washer is available in 5.5mm to 13mm. The Screws
are intended for standalone use. |
| Indications for Use: | The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of small bones of the hand or foot or small and large bones.
Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur. |
| Performance Data: | The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:
- Torsional
- Pullout
- 3-Point Bending
The nonclinical tests and engineering analysis demonstrate that the TDM Screw System is as safe, as effective, and is substantially equivalent to the legally marketed predicate device. |
| Predicate Device: | Primary predicate: TDM Co. Ltd. – TDM Screw Systems (K190830). |
| Technological
Characteristics | The TDM Screw System was shown to be substantially equivalent and has equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, function, range of sizes, and packaging. |
| Performance and SE
Determination: | The TDM Screw 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). |
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