(63 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is designed for the fixation of fractures and nonunions, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as plates and screws intended for fixation of fractures and nonunions of the distal tibia and fibula, which are used in treatment (fixation) rather than diagnosis.
No
The device description explicitly states that the system includes plates, screws, and reusable instrumentation, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of fractures, and nonunions of the distal tibia and fibula." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "Ankle Fracture Plating System" including plates, screws, and instrumentation. These are physical implants and surgical tools.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on specimens.
The device is a surgical implant system used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, and nonunions of the distal tibia and fibula such as:
- · Lateral Malleolar Fractures
- · Syndesmosis Injuries
- · Medial Malleolar Fractures
- Bi-Malleolar Fractures
- · Tri-Malleolar Fractures
- Posterior Malleolar Fractures
- Distal Anterior Tibia Fractures
- · Vertical Shear Fractures of the Medial Malleolous
- · Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- · Distal Tibia Periarticular Fractures
- · Medial Malleolar Avulsion Fractures
- · Lateral Malleolar Avulsion Fractures
The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture 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.
Product codes
HRS, HWC
Device Description
Medline UNITE® Ankle Fracture Plating System are manufactured from Titanium Alloy. The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.7mm and 3.5mm diameter locking cortical screws, 4.0mm Cancellous Screws, 4.0mm Medial Hook plate screws and 4.0mm Headed Cannulated screws to be used with the polyaxial locking holes and compression slots included in the plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. A comparison of the subject and predicate plates and screws is included below in Tables 2 through Tables 11. Additional detail regarding manufacturing process and product specifications can be found in Appendix B. The Medline Ankle Fracture Plates and Screws are within the currently marketed sizes and indications for use of the identified predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia and fibula
Indicated Patient Age Range
Not Found
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)
Single Cycle 4-point Bend Testing: The purpose of this test was to ensure that the bending stiffness of the proposed Medline Ankle Fracture Plates was equivalent to the bending stiffness of the predicate Synthes Plates, and to determine the 0.2% offset bending strength to be applied for fatigue testing.
Bending Fatigue Testing: The purpose of this test was to ensure that the fatigue life of the proposed Medline Ankle Plates was equivalent to that of the predicate, Synthes Plates.
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.
K011335, K082072, K091243, K102429, K151235, K130319
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
§ 888.3030 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K162829
Trade/Device Name: Medline UNITE® Ankle 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, HWC Dated: October 5, 2016 Received: October 7, 2016
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Image /page/1/Picture/8 description: The image shows the name "Caroline Rhim -S" in a simple, sans-serif font. The text is black and appears to be the main focus of the image. The background is a light blue color, with a watermark of the letters "FDA" in a larger font size.
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162829
Device Name
Medline UNITE® Ankle Fracture Plating System
Indications for Use (Describe)
Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, and nonunions of the distal tibia and fibula such as:
- · Lateral Malleolar Fractures
- · Syndesmosis Injuries
- · Medial Malleolar Fractures
- Bi-Malleolar Fractures
- · Tri-Malleolar Fractures
- Posterior Malleolar Fractures
- Distal Anterior Tibia Fractures
- · Vertical Shear Fractures of the Medial Malleolous
- · Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- · Distal Tibia Periarticular Fractures
- · Medial Malleolar Avulsion Fractures
- · Lateral Malleolar Avulsion Fractures
The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture 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.
| 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 features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst or cross-like symbol. The starburst is white and appears to be centrally aligned with the text, creating a visually balanced composition. A small gray rectangle is visible in the upper right corner of the image.
ledline Industries, Inc. One Medline Place Mundelein. IL 60060
K162829 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date December 8, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Medline UNITE® Ankle Fracture Plating System Proprietary Name: Medline UNITE® Ankle Fracture Plating System Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS: Plate, Fixation, Bone HWC: Screw, Fixation Bone Classification Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3030
Predicate Device
The following 510(k) clearance letters (Appendix C), supporting this system, have been identified: K011335 (Primary) - Synthes One Third Tubular Plate K082072 - Synthes (USA) 3.5mm LCP Hook Plate K091243 - ORTHOLOC™ Ankle Plating System K102429 - ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC Bone Screws
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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, bold, sans-serif font. Above and below the word is a white, stylized cross shape, with the top and bottom points being longer than the side points.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
K151235 - Medline Foot Plates and Screws K130319 – Medline Cannulated Screws
Device Description
Medline UNITE® Ankle Fracture Plating System are manufactured from Titanium Alloy. The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.7mm and 3.5mm diameter locking cortical screws, 4.0mm Cancellous Screws, 4.0mm Medial Hook plate screws and 4.0mm Headed Cannulated screws to be used with the polyaxial locking holes and compression slots included in the plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. A comparison of the subject and predicate plates and screws is included below in Tables 2 through Tables 11. Additional detail regarding manufacturing process and product specifications can be found in Appendix B. The Medline Ankle Fracture Plates and Screws are within the currently marketed sizes and indications for use of the identified predicate devices.
Indications for Use
Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, osteotomies and nonunions of the distal tibia and fibula such as:
-
- Lateral Malleolar Fractures
-
- Syndesmosis injuries
-
- Medial Malleolar Fractures
-
- Bi-Malleolar Fractures
- Tri-Malleolar Fractures
- Posterior Malleolar Fractures
-
- Distal Anterior Tibia Fractures
- Vertical Shear Fractures of the Medial Malleolous
- Pilon Fractures
-
- Distal Tibia Shaft Fractures
-
- Distal Fibula Shaft Fractures
-
- Distal Tibia Periarticular Fractures
-
- Medial Malleolar Avulsion Fractures
-
- Lateral Malleolar Avulsion Fractures
The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture 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.
5
Image /page/5/Picture/0 description: The image features the Medline logo, which consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The logo is set against a solid blue square background. A small portion of a gray rectangle is visible in the upper right corner of the image.
dline Industries. Inc ne Medline Place Mundelein II 60060
Summary of Technological Characteristics
The proposed device is substantially equivalent to the predicate. The Synthes One Third Tubular Plate K011335 was selected as the predicate based on the same intended use and similar materials.
Summary of Non-Clinical Testing
The following tests were performed in accordance with ASTM F382-14 standard to demonstrate substantial equivalence between the proposed Medline Ankle Fracture Plates and the primary predicate Synthes LCP One Third Tubular Plate.
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 Ankle Fracture Plates was equivalent to the bending stiffness of the predicate Synthes Plates, and to determine the 0.2% offset bending strength to be applied for fatigue testing.
Bending Fatigue Testing
Bending fatigue testing was performed per ASTM F382. The purpose of this test was to ensure that the fatigue life of the proposed Medline Ankle Plates was equivalent to that of the predicate, Synthes Plates.
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® Ankle Fracture Plating System is as safe and as effective as the predicate, the Synthes LCP One Third Tubular Plates.