(25 days)
No
The 510(k) summary describes bone screws and washers, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as screws intended for bone reconstruction, fracture repair, and fixation, which are structural and mechanical functions rather than therapeutic.
No
Explanation: The device is described as bone screws intended for surgical procedures like bone reconstruction and fracture repair, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a system of bone screws and washers made of titanium alloy, which are physical 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 describes the device as being used in the body for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are all surgical procedures performed directly on the patient's bone.
- Device Description: The description details bone screws and washers made of titanium alloy or stainless steel, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the LTJ Screws and Washer system is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.
Product codes
HWC, HTN
Device Description
The purpose of this Special 510(k) is to add additional references to the LTJ Screws and Washer system. These new references are provided in titanium alloy compliant with ASTM F136 and have the same design and dimensions as the cleared LTJ Screws and Washer provided in stainless steel alloy compliant with ASTM F138.
The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. The headless implants can be associated to an LTJ diameter 8 mm Washer. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
skeletally mature patient
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)
Mechanical testing was performed under ASTM F543 requirements. These tests showed the subject device to be substantially equivalent in terms of performance to the predicate LTJ Screws and Washer (K200987).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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February 26, 2021
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AzurMeds Inc. Jean-Marie Berger Chief Commercial Officer 4809 N Ravenswood Avenue Suite 119 Chicago, Illinois 60604
Re: K210268
Trade/Device Name: LTJ Screws and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: January 29, 2021 Received: February 1, 2021
Dear Jean-Marie Berger:
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.
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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) 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 (OS) 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, 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210268
Device Name LTJ Screws and Washer
Indications for Use (Describe)
The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.
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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Page 1 of 2
Image /page/3/Picture/2 description: The image shows the logo for Azur Meds. The word "Azur" is in a large, blue, sans-serif font, with the "A" slightly larger than the other letters. Below "Azur" and slightly to the right is the word "Meds" in a smaller, black, sans-serif font. The overall design is simple and clean.
510(k) Summary
AzurMeds., Inc's LTJ Screws and Washer
Date prepared: January 29, 2021
| Assigned 510(k) number: | - |
|---|---|
| Company: | AzurMeds Inc. |
| 4809 N Ravenswood Ave 119 | |
| CHICAGO, IL, 60640, | |
| USA | |
| Phone: + 1 (773)-564-9324 | |
| Cell: + 1 (612) 810-7221 | |
| Contact: | Jean-Marie Berger |
| Trade/Proprietary Name: | LTJ Screws and Washer |
| Regulation & Classification | |
| Name: | (Primary) 21 CFR 888.3040 - Smooth or threaded metallic bone fixation |
| fastener | |
| 21 CFR 888.3030 - Single/multiple component metallic bone fixation | |
| appliances and accessories | |
| Device Classification: | Class II |
| Product Code & Common | |
| Name: | HWC (Screw, Fixation, Bone) |
| HTN (Washer, Bolt Nut) | |
| Predicate Devices: | (Primary predicate): LTJ Screws and Washer (K200987) |
| (Reference predicate): Monster Screw System™ (K124027) | |
| Device Description: | The purpose of this Special 510(k) is to add additional references to the |
| LTJ Screws and Washer system. These new references are provided in | |
| titanium alloy compliant with ASTM F136 and have the same design and | |
| dimensions as the cleared LTJ Screws and Washer provided in stainless | |
| steel alloy compliant with ASTM F138. | |
| The LTJ Screws are partially threaded solid headless 3.75 mm screws and | |
| partially threaded cannulated headed 4.5 mm screws provided in various | |
| length ranging from 26 mm to 50 mm. The headless implants can be |
4
associated to an LTJ diameter 8 mm Washer. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.
The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to Intended Use and indications be used in skeletally mature patient as stand-alone bone screws for bone for use: reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Optional washers are available for the 3.75 solid screws.
Mechanical testing was performed under ASTM F543 requirements. Technology Comparison and These tests showed the subject device to be substantially equivalent in Non-Clinical Performance terms of performance to the predicate LTJ Screws and Washer Testing: (K200987).
Conclusion: There are no substantial differences between the new references of LTJ Screws and Washer and the predicate devices with respect to intended use and technological characteristics, including design, materials of manufacture, mechanical properties, and intended effect.
Therefore, the LTJ Screws and Washer can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.