(160 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as screws for orthopedic procedures such as fracture repair and bone reconstruction, which are used to mechanically support or fix bone, not to treat or cure a disease or condition.
No
The device description indicates that the LTJ Screws are used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are therapeutic and structural support functions, not diagnostic ones.
No
The device description clearly states it is a physical screw made of stainless steel, intended for surgical implantation. It also mentions associated instruments and mechanical testing, all indicative of a hardware device.
No, 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 description clearly states that the LTJ Screws are intended for surgical procedures involving bone (bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fixation). They are physical implants used within the body, not for testing samples outside the body.
The information provided describes a surgical implant, not a diagnostic test.
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, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Optional washers are available for the 3.75 solid screws.
Product codes
HWC, HTN
Device Description
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. They are provided in Stainless Steel Alloy compliant with ASTM F138. The headless implants can be associated to an LTJ diameter 8 mm Washer provided in Stainless Steel Alloy compliant with ASTM F138. 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
Mechanical testing of the worst-case LTJ Screws included torque strength, insertion/removal torque and pullout performed according to ASTM F543. The mechanical test results demonstrated that the LTJ Screws and Washer are adequate for their intended use.
Key Metrics
Not Found
Predicate Device(s)
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.
0
September 22, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
AzurMeds inc. Jean-Marie Berger Chief Commercial Officer 4809 N Ravenswood Avenue Suite 119 Chicago, Illinois 60604
Re: K200987
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: September 9, 2020 Received: September 11, 2020
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.
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
1
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 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,
for - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200987
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for "Azur Meds". The word "Azur" is in a larger, bold, blue font, with the "A" slightly larger than the rest of the word. The word "Meds" is in a smaller, bold, blue font and is located below and to the right of "Azur".
510(k) Summary AzurMeds., Inc's LTJ Screws and Washer
Date prepared: September 17th, 2020
| Assigned 510(k) number: | K200987 |
|---|---|
| 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 | |
| Product Code & Common Name: | HWC (Screw, Fixation, Bone) |
| HTN (Washer, Bolt Nut) | |
| Primary Predicate Device: | Monster Screw System™ (K124027) |
1. Device Description
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. They are provided in Stainless Steel Alloy compliant with ASTM F138. The headless implants can be associated to an LTJ diameter 8 mm Washer provided in Stainless Steel Alloy compliant with ASTM F138. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.
2. 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, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Optional washers are available for the 3.75 solid screws.
3. Comparison of Technological Characteristics with the Predicate Device
The subject and predicate screws are both metallic screw systems that contain similar diameters and lengths. The subject system differs from the predicate system because it contains a subset of diameters and lengths, it is manufactured out of a different grade of stainless steel and contains a different thread profile.
4
4. Performance data
Mechanical testing of the worst-case LTJ Screws included torque strength, insertion/removal torque and pullout performed according to ASTM F543. The mechanical test results demonstrated that the LTJ Screws and Washer are adequate for their intended use.
5. Conclusion
LTJ Screws and Washer possess the same intended use, similar indications, and same principles of operation as its predicate device. While the LTJ Screws and Washer are not identical to the predicate devices, comparisons of the subject and predicate devices confirmed that any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. Therefore, the LTJ Screws and Washer system is substantially equivalent to currently marketed predicate device for its intended use.