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.

Device Description

AI/ML Overview

The document describes the Medline UNITE® Ankle Fracture Plating System and its substantial equivalence to predicate devices, particularly the Synthes LCP One Third Tubular Plate (K011335).

Here's an analysis of the acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Mechanical Performance (Single Cycle 4-point Bend Testing)	Bending stiffness equivalent to predicate (Synthes LCP One Third Tubular Plate).	Based on ASTM F382-14 standard. Demonstrated equivalence to predicate, suggesting the device meets established mechanical performance standards for bone plates.
Mechanical Performance (Bending Fatigue Testing)	Fatigue life equivalent to predicate (Synthes LCP One Third Tubular Plate).	Based on ASTM F382-14 standard. Demonstrated equivalence to predicate, indicating similar durability and resistance to wear under cyclical loading.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing involving mechanical tests (single-cycle 4-point bend testing and bending fatigue testing).
The sample size for these mechanical tests is not explicitly stated in the provided text.
Data provenance is also not applicable in the context of mechanical testing of physical implants rather than patient data. The tests were performed to compare the Medline device against a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to the type of testing performed. The study involved non-clinical mechanical testing of medical devices, not clinical evaluation requiring expert interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical mechanical testing, not a clinical study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. The document states "Summary of Clinical Testing: Not applicable." The study was entirely non-clinical, focusing on mechanical properties.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable as the device is a physical bone plating system, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was the established mechanical performance characteristics of the predicate device, as defined by the ASTM F382-14 standard and the performance of the Synthes LCP One Third Tubular Plate. Equivalence to these established benchmarks was the goal.

8. Sample Size for the Training Set

This information is not applicable as there was no training set in the context of this mechanical device testing.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there was no training set mentioned in the context of this mechanical device testing.

Summary

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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

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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.

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for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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

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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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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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

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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.

Regulation Number and Section

§ 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.