(165 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 intended for fixation of fractures, fusions, non-unions, and malunions, which are medical treatments.
No
Explanation: The TDM Screw Systems are described as devices for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions. They are used for treatment and repair, not for detecting or diagnosing medical conditions.
No
The device description explicitly states that the TDM Screw Systems are constructed from Titanium alloy and are comprised of physical components like cannulated screws, headless compression cannulated screws, limited sliding screws, compression screws, and washers. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TDM Screw Systems are for the fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device description details the physical components (screws, washers) and their material (Titanium alloy). These are implants designed for mechanical support within the body.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This document contains none of these characteristics. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical testing (three-point bend testing) and bacterial endotoxin testing, which are relevant for implantable devices, not IVDs.
In summary, the TDM Screw Systems are surgical implants used for bone fixation, which is a therapeutic procedure performed directly on the patient, not an in vitro diagnostic test.
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 (2.5mm) or small and large bones (4.0mm larger).
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 (2.3mm & 4.0mm) and fixation of intraarticular fractures of the humerus. femur and tibia (3.5mm & 5.0mm).
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.
Product codes
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 120mm. 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, small bones, large bones, 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: Non-clinical testing (mechanical testing)
Sample Size: Not explicitly stated
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results: Performance testing was performed in accordance with ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Bone Screws". ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices" served as a guideline for the methods of screw three-point bend testing. The mechanical test data demonstrates that the TDM Screw Systems are adequate for their intended use. LAL bacterial endotoxin testing was conducted. Clinical data was not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K161616, K123890, K021556, K050636, K080943, K063020
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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September 13, 2019
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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
TDM Co. Ltd. % Sevrina Ciucci Regulatory Consultant Lince Consulting LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K190830
Trade/Device Name: TDM Screw Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 29, 2019 Received: April 1, 2019
Dear Sevrina Ciucci:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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. MPH 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
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Indications for Use
510(k) Number (if known) K190830
Device Name TDM Screw Systems
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 (2.5mm) or small and large bones (4.0mm larger).
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 (2.3mm & 4.0mm) and fixation of intraarticular fractures of the humerus. femur and tibia (3.5mm & 5.0mm).
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.
| 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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510(k) Summary
| DATE PREPARED | September 9, 2019 |
|---|---|
| APPLICANT | TDM Co. Ltd. |
| 69, Cheomdan Venture So-ro, 37 beon-gil, | |
| Buk-gu, Gwangju, 61003 | |
| Republic of Korea | |
| Phone: 82-62-971-7460 | |
| Fax: 82-62-971-7461 | |
| Establishment Registration No.: 3014257776 | |
| APPLICATION | |
| 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 Screw Systems |
| COMMON NAME | Screw, Fixation, Bone |
| Washer, Bolt Nut | |
| PRODUCT CODE(S); CFR | |
| CLASSIFICATION AND | |
| NAME | HWC; 21 CFR§888.3040 Smooth or threaded metallic bone |
| fixation Fastener | |
| HTN; 21 CFR§888.3030 Single/multiple component metallic | |
| bone fixation appliances and accessories | |
| PRIMARY PREDICATE | |
| DEVICES | K161616 Synthes Cannulated, Cortex, and Headless |
| Compression Screws | |
| ADDITIONAL PREDICATE | |
| DEVICES | K123890 Acumed Cannulated Screw System |
| K021556 Synthes 2.4mm Cannulated Compression Screw | |
| K050636 Synthes 3.0mm Headless Compression Screws | |
| K080943 Synthes 4.5 mm and 6.5 mm Headless Compression | |
| Screws | |
| K063020 INTAI Bone Screw System | |
| 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 | |
| INTENDED USE | are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging from 10mm to 120mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone 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 (2.5mm) or small and large bones (4.0mm larger).
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 (2.3mm & 3.5mm, 3.0mm & 4.0mm) and fixation of intra-articular fractures of the humerus, femur and tibia (3.5mm & 5.0mm).
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments. |
| COMPARISON TO
PREDICATE INDICATIONS | The subject TDM Screw Systems and the predicate systems are intended to be used for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device. All indications for the subject device are within the indications of the predicate devices. |
| COMPARISON TO
PREDICATE
TECHNOLOGICAL
CHARACTERISTICS | The components of the TDM Screw Systems possess the same technological characteristics as the predicate devices and these include:
• performance,
• basic design,
• material, manufacturing, and
• sizes (dimensions are comparable to those offered by the predicate systems). |
| | Differences between the TDM Screw Systems and the predicate devices are considered minor and were not shown to raise new questions concerning safety and effectiveness. |
| SUMMARY OF NON-
CLINICAL TESTING | 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 F543-17, "Standard Specification and Test Methods for Metallic Medical Bone Screws". ASTM F1264-16 “Standard Specification and Test Methods for Intramedullary Fixation Devices" served as |
4
5
a guideline for the methods of screw three-point bend testing. The mechanical test data demonstrates that the TDM Screw Systems are adequate for their intended use. LAL bacterial endotoxin testing was conducted. Clinical data was not needed for this device.
- Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, the TDM Screw Systems are substantially equivalent to currently marketed predicate devices.