(30 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended surgical use of bone screws, with no mention of AI or ML technology.
No.
The device is a screw used for fixation and repair of bones, which is a structural or mechanical function rather than a therapeutic one.
No
Explanation: The device is a surgical screw used for bone fixation and reconstruction, not for diagnosis. Its intended use explicitly states "bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures."
No
The device description explicitly states it is manufactured from titanium alloy and describes physical dimensions (diameters and lengths), indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Medline UNITE® Jones Fracture Screws are described as implants made of titanium alloy used for bone reconstruction, fracture fixation, and other orthopedic procedures. They are surgically implanted into the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from a patient.
Therefore, based on the provided information, the Medline UNITE® Jones Fracture Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Medline UNITE® Jones Fracture Screws are manufactured from titanium alloy. The screws are offered in various diameters ranging from 4.5mm up to 6.0mm and overall lengths ranging from 34mm up to 65mm with consistent thread lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fifth metatarsal (Jones fracture)
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)
ASTM F543 testing (insertion torque testing, torsional strength testing, and axial pullout strength testing) and engineering analysis were used to compare screw mechanical performance, fixation performance and usability.
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.
K130319 - Medline Cannulated Screw, K183026 - Wright Jones Fracture System
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.
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 it.
June 17, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60030
Re: K201319
Trade/Device Name: Medline UNITE Jones Fracture Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: May 15, 2020 Received: May 18, 2020
Dear Jennifer Mason:
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, 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)
K201319
Device Name Medline UNITE Jones Fracture Screw System
Indications for Use (Describe)
The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.
| 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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K201319 510(K) Summary [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date June 16, 2020
Type of 510(k) Submission Special
Device Name / Classification
Name of Device: Medline UNITE® Jones Fracture Screw System Proprietary Name: Medline UNITE® Jones Fracture Screw System Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Product Code: HWC, HTN Classification Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3040 (Primary) and 21 CFR 888.3030
Predicate Device
K130319 - Medline Cannulated Screw (Primary) K183026 - Wright Jones Fracture System
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Device Description
The Medline UNITE® Jones Fracture Screws are manufactured from titanium alloy. The screws are offered in various diameters ranging from 4.5mm up to 6.0mm and overall lengths ranging from 34mm up to 65mm with consistent thread lengths.
Indications for Use
The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies. arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.
The indications for use differ from the primary predicate because they contain more specific indications for use that are consistent with other screws cleared under 21 CFR 888.3040. These differences are not critical to the intended therapeutic affect because the more specific indications fall within the intended use of fracture fixation.
Summary of Technological Characteristics
The proposed modified device is substantially equivalent to the primary predicate, the Medline Cannulated Screw. A discussion or similarities and differences is listed below.
- Intended use identical. ●
- Indications for Use - similar. The indications for use for the Jones Fracture Screws are more specific than the predicate but still fall under the same intended use of fracture fixation.
- Materials identical. Both the subject device and the predicate device are made from titanium ● alloy per ASTM F136.
- Geometry and Size similar. The subject device will be offered in diameters of 4.5mm, 5.5mm ● and 6.0mm with lengths ranging from 34mm - 65mm. These diameters and lengths are within the diameters and lengths of the predicate device which ranges from 2.0mm to 7.5mm in diameter and 10mm to 130mm in length.
- Design Feature similar. The Jones Fracture Screws are solid core screws, whereas, the predicate ● screws are cannulated. Both the subject device and the predicate device feature a torx drive mechanism. The predicate device is self-drilling and self-tapping. The subject device is only selfdrilling to reduce the risk of penetrating the far cortex of the 5th metatarsal which would lead to bi-
5
cortical fixation. Intramedullary fixation rather than bi-cortical fixation is typically preferred in 5th metatarsal fracture fixation.
Summary of Non-Clinical Testing
ASTM F543 testing (insertion torque testing, torsional strength testing, and axial pullout strength testing) and engineering analysis were used to compare screw mechanical performance, fixation performance and usability.
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline UNITE® Jones Fracture Screws are substantially equivalent to the predicate device, the Medline Cannulated Screw.