(141 days)
No
The 510(k) summary describes a system of plates and screws for ankle fusion, made of titanium alloy. There is no mention of software, algorithms, image processing, AI, ML, or any other technology that would suggest the use of artificial intelligence or machine learning. The performance testing described is bench testing of mechanical properties.
Yes
The device is indicated for arthrodesis, reconstruction of bones, and fracture fixation, all of which aim to treat or alleviate disease, injury, or conditions.
No
This device is a surgical implant system designed for arthrodesis (fusion) of ankle joints and fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly details physical hardware components, including plates, screws, and surgical instrumentation, all made from Titanium Alloy. There is no mention of software as a component of this system.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes the Medline UNITE® Ankle Fusion Plating System as a system of plates and screws made of titanium alloy, intended for surgical use in arthrodesis (fusion) of ankle and foot joints, fracture fixation, and bone reconstruction.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and surgical, providing structural support and fixation within the body.
Therefore, based on the provided information, the Medline UNITE® Ankle Fusion Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiocalcaneal arthrodeses, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the device. The system can be used in both adult and pediatric (adolescent and child) patients.
Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws, which span an active growth plate in a pediatric patient, should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.
Product codes
HRS, HWC
Device Description
The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle including tibiotalocalcaneal and tibiocalcaneal, feet and ankles.
Indicated Patient Age Range
adult and pediatric (adolescent and child) patients
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
Performance Testing (Bench): The subject Medline UNITE® Ankle Fusion Plates do not represent a new worst-case when compared to the previously cleared Medline UNITE® Calcaneal Fracture Plates (K213567). Additionally, mechanical testing of the subject Medline UNITE® Ankle Fusion Plates and the ParaLock Plates (K140397) demonstrated substantially equivalent mechanical performance of the subject devices. An engineering analysis was performed to determine the subject screws do not present a new worst-case for yield strength, axial pullout, and torsional strength when compared to the predicate Medline Foot Screws (K151235). Based on this analysis, the subject Medline UNITE® Ankle Fusion Plating System is substantially equivalent to the predicate devices.
Performance Testing (Animal): This section does not apply. No animal testing was performed.
Performance Testing (Clinical): This section does not apply. No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
K213567, K121425, K151235, K140397
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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January 24, 2023
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 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.
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093
Re: K222665
Trade/Device Name: Medline UNITE® Ankle Fusion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: December 22, 2022 Received: December 22, 2022
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
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-S
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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Indications for Use
510(k) Number (if known) K222665
Device Name Medline UNITE® Ankle Fusion Plating System
Indications for Use (Describe)
The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiocalcaneal arthrodeses, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the device. The system can be used in both adult and pediatric (adolescent and child) patients.
Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws, which span an active growth plate in a pediatric patient, should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.
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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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a white starburst symbol to the right of the text. The background of the logo is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
K22665 SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Contact Person: Jennifer Mason, Principal Regulatory Affairs Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date January 24, 2023
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline UNITE® Ankle Fusion Plating System Common Name: Plate, Fixation, Bone Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener Product Code: HRS, HWC Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040
Primary Predicate Device
Medline UNITE® Calcaneal Fracture Plating System K213567
Predicate Device
ORTHOLOC 3 Di Ankle Fusion Plating System K121425
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Image /page/4/Picture/0 description: The image is a logo for Medline. The logo is a blue square with the word "MEDLINE" in white letters on the left side of the square. To the right of the word is a white symbol that looks like a stylized cross or plus sign. The background is a solid blue color.
Medline Industries. LP Three Lakes Drive Northfield, IL 60093
Predicate Device
Medline Foot Plates and Screws K151235
Predicate Device
Paragon28 ParaLock Plating System K140397
Device Description
The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.
Indications for Use
The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodesis, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system can be used in both adult and pediatric (adolescent and child) patients.
Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws which span an active growth plate in a pediatric patient. should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.
Summary of Technological Characteristics
The proposed device is substantially equivalent to the primary predicate, Medline UNITE® Calcaneal Fracture Plating System. A discussion of similarities and differences is listed below.
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
- Intended Use identical. Both the proposed device and the predicate device are intended for ● stabilization of fresh fractures, revision procedures, and reconstruction of bones in the fee and ankles.
- Indications for Use similar. The indications for use of the subject device is identical to the . indications for use of the predicate device, however, Medline is requesting to add more specific ankle indications that still fall under the original indications for use and do not result in a new intended use.
- Materials identical. The proposed device and the predicate device are both from titanium alloy. .
- Plate Configuration - identical. Both the proposed plates and the predicate plates are offered in both left/right and universal configurations.
- Design Features - similar. Both the proposed plates and the predicate plates feature polyaxial locking up to 15-degrees. The proposed plates also include compression slots.
- Screw Lengths and Diameters similar. Both the subject screws and the predicate screws will be ● offered in 4.5 and 5.5mm diameters. The subject screws are longer than the primary predicate, however, the screws are not as long as the Wright Medical ORTHOLOC 3Di Ankle Fusion Screws.
Summary of Non-Clinical Testing
Performance Testing (Bench)
The subject Medline UNITE® Ankle Fusion Plates do not represent a new worst-case when compared to the previously cleared Medline UNITE® Calcaneal Fracture Plates (K213567). Additionally, mechanical testing of the subject Medline UNITE® Ankle Fusion Plates and the ParaLock Plates (K140397) demonstrated substantially equivalent mechanical performance of the subject devices. An engineering analysis was performed to determine the subject screws do not present a new worst-case for yield strength, axial pullout, and torsional strength when compared to the predicate Medline Foot Screws (K151235). Based on this analysis, the subject Medline UNITE® Ankle Fusion Plating System is substantially equivalent to the predicate devices.
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical)
This section does not apply. No clinical testing was performed.
Summary of Clinical Testing
Not applicable.
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Medline Industries, LP 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® Ankle Fusion Plating System are as safe and as effective for their intended use as the predicate device, Medline UNITE® Calcaneal Fracture Plating System (K213567).