The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, and nonunions of the distal tibia and fibula such as:

· Medial Malleolar Fractures
· Lateral Malleolar Fractures
· Syndesmosis Injuries
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Vertical Shear Fractures of the Medial Malleolus
· Medial Malleolar Avulsion Fractures
· Lateral Malleolar Avulsion Fractures

In addition, the Medline UNITE® Locking Pegs, when used in conjunction with the Medline UNITE® Mini Plates and Screws, are indicated for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric (adolescent and child) patients.

Device Description

The Medline UNITE® Medial Malleolar Peg Plate System consists of implants manufactured from Titanium Alloy (Ti-6Al-4V ELI). The system includes plates offered in two sizes. The plates can accommodate Ø2.7mm. Ø3.5mm. and Ø4.0mm locking and non-locking screws and Ø2.0mm locking pegs. The system also includes reusable instrumentation necessary to implant the plates, screws, and pegs, e.g. plate inserter. wire sleeve.

AI/ML Overview

This FDA 510(k) premarket notification describes the Medline UNITE® Medial Malleolus Peg Plate System. It is important to note that this document is for a medical device (a bone fixation system) and not for an AI/software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study aspects related to AI/SaMD (like ground truth, expert consensus, MRMC studies, training set size, etc.) are not applicable to this submission.

The "acceptance criteria" for a medical device like this are primarily based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance and biocompatibility testing.

Here's a breakdown of the information provided, tailored to a mechanical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Conformity to ASTM F136 or ISO 5832-3 (Titanium Alloy).	Manufactured from titanium alloy conforming to ASTM F136 or ISO 5832-3. Leveraged biocompatibility data from the predicate device as they use identical raw material and manufacturing process.
Mechanical Performance	Device does not represent a new worst-case for mechanical properties (e.g., torsional yield strength) when compared to the predicate device.	An engineering analysis was performed to determine that the subject screws do not present a new worst-case for torsional yield strength compared to the predicate. Based on this analysis, the subject device is substantially equivalent.
Functional/Design Equivalence	Intended Use and Indications for Use are identical or substantially similar to the predicate. Materials are identical. Design features (e.g., polyaxial locking, screw compatibility) are similar. Design configurations (universal) are similar. Peg lengths and diameters are similar or identical.	Intended Use identical to predicate. Indications for Use similar (subject device has more narrowed indications). Materials (titanium alloy) identical. Design features (polyaxial locking up to 15 degrees, compatibility with 2.7mm, 3.5mm, 4.0mm screws) similar. Design configurations (universal) similar. Peg lengths (10mm-60mm) are longer than predicate (16mm) but comparable to a reference device's screws. Peg diameters (2.0mm) identical to predicate.

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

Test Set: No discrete "test set" in the context of clinical data for AI/SaMD. The evaluation is based on engineering analysis and material testing.
Data Provenance: The data comes from bench testing (engineering analysis) comparing the subject device's design, materials, and mechanical properties to predicate devices. This is not patient-specific data.

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

Not applicable. This is a medical device, not an AI/SaMD. "Ground truth" for an AI algorithm, established by experts, is not relevant here. The "truth" is established through material standards, engineering principles, and mechanical testing results.

4. Adjudication Method for the Test Set

Not applicable. No human interpretation or adjudication of an "AI output" is involved. The evaluation is based on objective engineering comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/SaMD. MRMC studies are used to assess the impact of AI on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/SaMD. A "standalone algorithm" is not relevant for a bone fixation system.

7. The type of ground truth used

Not applicable in the context of AI/SaMD. For this medical device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Material Standards: Adherence to established ASTM/ISO standards for titanium alloy.
- Engineering Principles: Calculations and analysis demonstrating equivalent or superior mechanical performance compared to the predicate.
- Predicate Device Data: Leveraging existing safety and effectiveness data from legally marketed predicate devices with known performance.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/SaMD.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or its associated ground truth for this type of medical device submission.

Summary

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September 27, 2022

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

Medline Industries, LP Jennifer Mason Regulatory Affairs Principal Three Lakes Drive Northfield, Illinois 60093

Re: K221360

Trade/Device Name: Medline UNITE® Medial Malleolus Peg Plate 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: August 19, 2022 Received: August 26, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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

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Indications for Use

510(k) Number (if known) K221360

Device Name

Medline UNITE® Medial Malleolus Peg Plate System

Indications for Use (Describe)

· Medial Malleolar Fractures
· Lateral Malleolar Fractures
· Syndesmosis Injuries
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Vertical Shear Fractures of the Medial Malleolus
· 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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Image /page/3/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is composed of four pointed shapes converging at a central point. A small gray rectangle is visible in the upper right corner of the image.

1edline 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

Contact Person: Jennifer Mason, Senior Regulatory Affairs Principal Phone: 847-643-3652 Email: jamason@medline.com

Summary Preparation Date August 5, 2022

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline UNITE® Medial Malleolus Peg Plate 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: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 21 CFR 888.3040

Primary Predicate Device

Medline UNITE® Ankle Fracture Plating System K162829

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Medline Industries, LP Three Lakes Drive Northfield. IL 60093

Predicate Device

Stryker VariAx 2 System K132502

Medline UNITE® Mini Plates and Screws K181820

Reference Device Medline Foot Plates and Screws K151235

Device Description

Indications for Use

The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, osteotomies, and nonunions of the distal tibia and fibula such as:

. Medial Malleolar Fractures
Lateral Malleolar Fractures
Syndesmosis Injuries
Bi-Malleolar Fractures ●
Tri-Malleolar Fractures
. Vertical Shear Fractures of the Medial Malleolus
Medial Malleolar Avulsion Fractures ●
. Lateral Malleolar Avulsion Fractures

In addition, the Medline UNITE® Locking Pegs, when used in conjunction with the Medline UNITE® Mini Plates and Screws, are indicated for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. 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 primary predicate, Medline UNITE® Ankle Fracture Plating System. A discussion of similarities and differences is listed below.

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Medline Industries, Three Lakes Drive Northfield. IL 60093

Intended Use identical. The Medline UNITE Medial Malleolus Peg Plate System and the predicate ● device are both intended for fixation of fractures, osteotomies and nonunions of the distal tibia and fibula.
Indications for Use similar. The Medline UNITE® Medial Malleolus Peg Plate System has the . same indications for use as the predicate device, however, the subject device has more narrowed indications in comparison.
. Materials - identical. The proposed device and the predicate device are both made from titanium alloy.
. Design Features - similar. Both the proposed plates and the predicate device feature polyaxial locking up to 15 degrees. Both plates can be used with 2.7mm, 3.5mm and 4.0mm locking and nonlocking screws.
Design Configurations similar. Both the Medline UNITE® Medial Malleolus Peg Plates and the ● predicate plates are offered in a universal configuration. Although the predicate plates are also offered in left and right configurations, whereas, the proposed plates are not.
. Peg Lengths - similar. The Medline UNITE® Medial malleolus Pegs will be offered in lengths of 10mm to 60mm. The predicate pegs are offered in lengths of 16mm. Although the subject pegs are longer as compared to the predicate device, the 2.7mm, 3.5mm and 4.0mm Medline UNITE Foot Plating Screws which are being included as a reference device are available in lengths from 10mm up to 60mm.
. Peg Diameters - identical. The Medline UNITE® Medial Malleolus Pegs will be offered in a 2.0mm diameter which is the exact same diameter as the predicate VariAx 2 pegs.

Summary of Non-Clinical Testing

Biocompatibility Testing

The Medline UNITE® Medial Malleolus Peg Plate System is manufactured from titanium alloy conforming to ASTM F136 or ISO 5832-3. The subject device and the predicate device are both manufactured from the identical raw material using the same manufacturing process, therefore, biocompatibility testing was leveraged from the predicate submission to support biocompatibility on the subject device.

Performance Testing (Bench)

The subject device, the Medline UNITE® Medial Malleolus Peg Plate System, do not represent a new, worstcase when compared to the previously cleared Medline UNITE® Ankle Fracture Plating System. An engineering analysis was performed to determine that the subject screws do not present a new worst-case for

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ledline Industries. Three Lakes Drive Northfield. IL 60093

torsional yield strength when compared to the predicate. Based on this analysis, the subject device, Medline UNITE® Medial malleolus Peg Plate System, is substantially equivalent to the predicate, Mediine UNITE® Ankle Fracture Plating System.

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 Medial Malleolus Peg Plate System are as safe and as effective for their intended use as the predicate device, the Medline UNITE® Ankle Fracture Plating System K162829.

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.