(113 days)
No
The 510(k) summary describes a system of bone plates and screws for fracture fixation, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an implant system for stabilizing bone fractures, which is a therapeutic intervention.
No
Explanation: The device is a plating system intended for the stabilization and reconstruction of bone fractures, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components like plates, screws, and reusable instrumentation, which are hardware.
Based on the provided text, the Medline UNITE® Calcaneal Fracture Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the system is for the stabilization of bone fractures and reconstruction in the feet and ankles. This is a surgical intervention on the body, not a test performed on samples taken from the body.
- Device Description: The device consists of plates, screws, and surgical instruments. These are all physical implants and tools used in surgery.
- No mention of testing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample to diagnose a condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.
Product codes
HRS
Device Description
The Medline UNITE® Calcaneal Fracture Plating System consists of 3 styles of Sinus Tarsi plates (Sinus Tarsi, Sinus Tarsi Offset, and Sinus Tarsi Extension) made from Titanium Alloy (Ti-6Al-4V ELI) and Perimeter plates made from Commercially Pure Titanium. The Sinus Tarsi Offset, and Sinus Tarsi Extension, and Perimeter plates are each offered in small, medium, and large sizes in left and right configurations. The plates can accommodate 2.7mm, 3.5mm and 4.0mm screws. Previously cleared 3.5mm locking and non-locking screws (K151235) that range from 10-60mm in length will be included in the tray with the Medline UNITE® Calcaneal Fracture Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. targeting guide, drill bits
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the feet and ankles including extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus.
Indicated Patient Age Range
adult and pediatric (adolescent and child) patients.
Intended User / Care Setting
Prescription Use
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)
Performance Testing (Bench):
Single Cycle 4-Point Bend Testing: Conducted per ASTM F382. Purpose was to ensure that the bending stiffness of the proposed Medline Unite® Calcaneal Plates were equivalent to the bending stiffness of the predicate. Results: The Medline Unite® Calcaneal Plates and the predicate Wright Medical ORTHOLOC® Calcaneal Plates are substantially equivalent in 4-point single cycle bend testing.
Bending Fatigue Testing: Conducted per ASTM F382. Purpose was to ensure that the bending fatigue of the proposed Medline Unite® Calcaneal Plates were equivalent to the bending fatigue of the predicate. Results: The Medline UNITE® Calcaneal Plates are substantially equivalent to the Wright Medical ORTHOLOC® CALC Fracture Plates in bending fatigue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wright Medical ORTHOLOC® Calcaneal Plating System K142121
Reference Device(s)
Tornier Calcaneal Fracture Plate System K090582, Medline Foot Plates and Screws K151235
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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Medline Industries, LP Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K213567
Trade/Device Name: Medline UNITE® Calcaneal Fracture 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 Dated: January 6, 2022 Received: January 10, 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.
1
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 (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, 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) K213567
Device Name
Medline UNITE® Calcaneal Fracture Plating System
Indications for Use (Describe)
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.
| 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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K213567 - Page 1 of 3
Image /page/3/Picture/1 description: The image is a logo for Medline. The logo features the word "MEDLINE" in a sans-serif font, with the letters stacked vertically. To the right of the word is a white star-like symbol with four points. The background of the logo is a solid blue color.
ledline Industries, LP Three Lakes Drive Northfield, IL 60093
510(k) 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
Jennifer Mason Senior Regulatory Affairs Specialist Medline Industries, LP Phone: 847-643-3652 Email: jamason(@medline.com
Summary Preparation Date February 22, 2022
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline UNITE® Calcaneal Fracture Plating System Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030
Predicate Device Wright Medical ORTHOLOC® Calcaneal Plating System K142121
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Image /page/4/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. A white, stylized starburst or cross shape is positioned behind the text, with its center aligned with the middle of the word "MEDLINE." The overall design is clean and professional, commonly associated with healthcare or medical supply companies.
Medline Industries, LP Three Lakes Drive Northfield. IL 60093
Reference Devices
Tornier Calcaneal Fracture Plate System K090582
Medline Foot Plates and Screws K151235
Device Description
The Medline UNITE® Calcaneal Fracture Plating System consists of 3 styles of Sinus Tarsi plates (Sinus Tarsi, Sinus Tarsi Offset, and Sinus Tarsi Extension) made from Titanium Alloy (Ti-6Al-4V ELI) and Perimeter plates made from Commercially Pure Titanium. The Sinus Tarsi Offset, and Sinus Tarsi Extension, and Perimeter plates are each offered in small, medium, and large sizes in left and right configurations. The plates can accommodate 2.7mm, 3.5mm and 4.0mm screws. Previously cleared 3.5mm locking and non-locking screws (K151235) that range from 10-60mm in length will be included in the tray with the Medline UNITE® Calcaneal Fracture Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. targeting guide, drill bits
Indications for Use
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used in both adult and pediatric (adolescent and child) patients.
Summary of Technological Characteristics
The proposed device is substantially equivalent to the predicate, Wright Medical ORTHOLOC® Calcaneal Plating System. A discussion of similarities and differences is listed below.
- Intended Use - identical. The subject device and the predicate device have the same intended use.
- Indications for Use similar. The indications for use for the Medline UNITE® Calcaneal Fracture ● Plating System are more specific than the predicate, but still fall under the same intended use.
- Materials similar. The proposed device and the predicate device are both made from CP4 ● titanium. The proposed device is also available in Ti-6Al-4V.
- . Design Features - identical. Both the proposed plates and the predicate feature polvaxial locking to 15 degrees. Both plates can be used with 3.5mm locking and non-locking screws.
- Design Configurations similar. The proposed plates and the predicate plates are both offered in ● left and right configurations. The predicate plates are reversible, whereas, the Medline plates are not.
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Image /page/5/Picture/1 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, sans-serif font, and is positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points.
edline Industries. L ree Lakes Drive Northfield II 60093
Summary of Non-Clinical Testing
Performance Testing (Bench)
The following tests were performed in accordance with ASTM F382 to demonstrate substantial equivalence between the proposed Medline UNITE® Calcaneal Fracture Plates and the predicate ORTHOLOC® Calcaneal Plates.
Single Cycle 4-Point Bend Testing
Single cycle 4-point bend testing was conducted per ASTM F382. The purpose of this test was to ensure that the bending stiffness of the proposed Medline Unite® Calcaneal Plates were equivalent to the bending stiffness of the predicate Wright Medical Plates. The Medline Unite® Calcaneal Plates and the predicate Wright Medical ORTHOLOC® Calcaneal Plates are substantially equivalent in 4-point single cycle bend testing.
Bending Fatigue Testing
Bending fatigue testing was conducted per ASTM F382. The purpose of this test was to ensure that the bending fatigue of the proposed Medline Unite® Calcaneal Plates were equivalent to the bending fatigue of the predicate Wright Medical Plates. Results from this testing demonstrate that the Medline UNITE® Calcaneal Plates are substantially equivalent to the Wright Medical ORTHOLOC® CALC Fracture Plates in bending fatigue.
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.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification. Medline Industries. Inc. concludes that the proposed Medline UNITE® Calcaneal Fracture Plating System is substantially equivalent to the predicate device, K142121 ORTHOLOC® Calcaneal Plating System.