(29 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic screw and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a surgical implant (screws) used for reconstruction, fracture repair, and fixation of bones, which are direct therapeutic interventions.
No
The device description clearly states its purpose as bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation, and it is manufactured from titanium alloy, acting as an implant rather than a tool for diagnosis.
No
The device description clearly states the device is a physical screw manufactured from titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Medline UNITE® Digital Fusion Screws are described as surgical implants made of titanium alloy, intended for use in bone reconstruction, fracture repair, and other orthopedic procedures. They are physically implanted into the body.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body.
- Anatomical Site: The device is used directly on bones within the body, not on specimens taken from the body.
The information provided clearly indicates that this is a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Medline UNITE® Digital Fusion Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities. Screws are intended for single use only.
Product codes
HWC
Device Description
The Medline UNITE® Digital Fusion Screws are manufactured from titanium alloy. The screws are nonsterile and will be offered in a 2.3mm diameter with various thread lengths and overall screw lengths ranging from 20mm up to 55mm in 5mm increments. The screws feature low profile headed and headless screws. The screws are self-drilling and self-tapping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities.
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)
Summary of Non-Clinical Testing
The subject device, Medline UNITE® Digital Fusion Screws, do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). However, analysis was conducted to further demonstrate substantial equivalence of the Medline UNITE® Digital Fusion Screws to the predicate. Medline Cannulated Screws. Based on this analysis, the subject device, Medline UNITE® Digital Fusion Screws, are substantially equivalent to the predicate, Medline Cannulated Screws, in predicted shear failure force (axial pullout force) and torsional yield strength.
Summary of Clinical Testing
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
July 22, 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K211944
Trade/Device Name: Medline UNITE® Digital Fusion 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: June 21, 2021 Received: June 23, 2021
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.
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
Indications for Use
510(k) Number (if known) K211944
Device Name Medline UNITE® Digital Fusion Screw System
Indications for Use (Describe)
The Medline UNITE® Digital Fusion Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities. Screws are intended for single use only.
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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3
Image /page/3/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a white star-like symbol behind it. The background of the logo is a solid blue color. The logo is simple and clean, and it is easily recognizable.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
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
Contact Person: Jennifer Mason, Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason(@medline.com
Summary Preparation Date June 21, 2021
Type of 510(k) Submission Special
Device Name / Classification
Trade Name: Medline UNITE® Digital Fusion Screw System Common Name: Smooth or threaded metallic bone fixation fastener Classification Name: Screw, Fixation, Bone Product Code: HWC Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3040
Predicate Device
Medline Cannulated Screws (Primary Predicate) K130319
PRO-TOE VO Hammertoe Implant System K101165
Device Description
The Medline UNITE® Digital Fusion Screws are manufactured from titanium alloy. The screws are nonsterile and will be offered in a 2.3mm diameter with various thread lengths and overall screw lengths ranging
4
Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, with a stylized white starburst symbol behind it. The background is a solid blue color. There is a gray bar on the right side of the image.
Medline Industries, Inc Three Lakes Drive Northfield. IL 60093
from 20mm up to 55mm in 5mm increments. The screws feature low profile headed and headless screws. The screws are self-drilling and self-tapping.
Indications for Use
The Medline UNITE® Digital Fusion Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device including corrective procedures for hammertoe, mallet toe, and claw toe deformities. Screws are intended for single use only.
Summary of Technological Characteristics
The proposed modified device is substantially equivalent to the primary predicate, Medline Cannulated Screws. A discussion of similarities and differences is listed below.
- o Intended use - identical.
- Indications for Use - similar. The indication for use for the Medline UNITE® Digital Fusion Screws are more specific than the predicate but still fall under the same intended use.
- Materials - identical. Both the proposed and predicate device are made from the same material, titanium alloy.
- Sizes - similar. The Medline UNITE Digital Fusion Screws will be offered in a 2.3mm diameter in leneths from 20 – 55mm. The predicate device has diameters ranging from 2.0 to 7.5mm with lengths ranging from 10 - 130mm. The diameters and lengths of the Medline UNITE® Digital Fusion Screws are within the diameters and lengths of the previously cleared Medline Cannulated Screws.
Summary of Non-Clinical Testing
The subject device, Medline UNITE® Digital Fusion Screws, do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). However, analysis was conducted to further demonstrate substantial equivalence of the Medline UNITE® Digital Fusion Screws to the predicate. Medline Cannulated Screws. Based on this analysis, the subject device, Medline UNITE® Digital Fusion Screws, are substantially equivalent to the predicate, Medline Cannulated Screws, in predicted shear failure force (axial pullout force) and torsional yield strength.
Summary of Clinical Testing
Not applicable.
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Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
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® Digital Fusion Screws are as safe and as effective for their intended use as the predicate device, the Medline Cannulated Screw.