Medline UNITE® IM Fibula Implants are in bone reconstruction, osteotomes, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Implants are intended for single use only.

Device Description

The Medline UNITE® IM Fibula Implants are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device. The Medline UNITE® IM Fibula Implants are manufactured from Titanium Alloy per ASTM F136 and ISO 5832-3. The implants are offered in a 3.7/4.0mm tapered diameter with fully threaded lengths ranging from 65mm to 150mm. The implants are single use only and provided non-sterile.

AI/ML Overview

The provided FDA 510(k) summary for the Medline UNITE® IM Fibula Implant (K220511) does not contain information about the acceptance criteria or a study proving that the device meets such criteria in terms of clinical performance or diagnostic accuracy. This type of device (a metallic bone fixation fastener) undergoes a different type of evaluation for substantial equivalence.

Here's why and what information is provided instead:

Device Type: This is a Class II medical device, specifically a smooth or threaded metallic bone fixation fastener. For such devices, the primary pathway to market clearance via a 510(k) is to demonstrate substantial equivalence to a currently marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials.
Focus of Evaluation: The evaluation for this type of device heavily relies on bench testing (non-clinical) to ensure mechanical properties, material biocompatibility, and design features are comparable or superior to the predicate device, and that it doesn't raise new questions of safety or effectiveness.

Therefore, the sections you've requested regarding acceptance criteria for clinical performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this 510(k) submission. These details are typically found in submissions for diagnostic AI/ML devices or other devices requiring clinical performance endpoints.

However, I can extract information related to the equivalence testing conducted for this device:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly state "acceptance criteria" in terms of specific thresholds for clinical performance metrics (like sensitivity, specificity, or surgical success rates). Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device (Medline Cannulated Screws, K130319) through a comparison of technological characteristics and non-clinical performance.

The primary "performance" reported is that the subject device's mechanical properties are comparable to or better than the predicate such that it does not represent a new worst-case.

Criterion Category (Implied for Substantial Equivalence)	Acceptance Criteria (Implied: Comparable to Predicate without raising new safety/effectiveness questions)	Reported Device Performance
Intended Use	Same as predicate	"Medline UNITE® IM Fibula Implants are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Implants are intended for single use only." (Which is the same as the predicate).
Technological Characteristics	Materials, Design, Sterility, Single Use, Prescription Status should be same or equivalent.	Materials: Titanium Alloy (Same as predicate). Design Feature: Torx drive mechanism, Self-drilling and self-tapping (Same as predicate). Prescription vs. OTC: Prescription (Same as predicate). Sterile vs. Non-Sterile: Non-Sterile (Same as predicate). Single Use vs Reusable: Single Use (Same as predicate).
Biocompatibility	Compatible with body tissue, no adverse biological reactions.	"manufactured from titanium alloy conforming to ASTM F136 and 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".
Mechanical Performance (Bench Testing)	Not a new worst-case for structural integrity (e.g., pullout force, torsional yield strength) compared to predicate.	"An engineering analysis was performed to determine that the subject screws do not present a new worst-case for pullout force and torsional yield strength when compared to the predicate."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The evaluation was based on non-clinical bench testing and engineering analysis, rather than a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable, as there was no clinical test set requiring expert ground truth for classification or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a bone fixation fastener, not an AI-powered diagnostic tool.

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

This information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. For this type of device, "ground truth" relates to material properties meeting specifications and device designs fulfilling mechanical performance requirements, assessed via engineering standards and tests.

8. The sample size for the training set

This information is not applicable. There was no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles, historical data, and established standards for medical implants.

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

This information is not applicable.

Summary

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March 22, 2022

U.S. FOOD & DRUG
ADMINISTRATION

Medline Industries, LP Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093

Re: K220511

Trade/Device Name: Medline UNITE® IM Fibula Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 15, 2022 Received: February 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

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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) K220511

Device Name Medline UNITE® IM Fibula Implant

Indications for Use (Describe)

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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Medline 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 Specialist Phone: 847-643-3652 Email: jamason@medline.com

Summary Preparation Date March 21, 2022

Type of 510(k) Submission Special

Device Name / Classification

Trade Name: Medline UNITE® IM Fibula Implant Common Name: Screw, Fixation Bone Classification Name: Smooth or threaded bone fixation fastener Product Code: HWC Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3040

Predicate Device

Medline Cannulated Screw: K130319

Device Description

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Medline Industries, LP Three Lakes Drive Northfield, IL 60093

A comparison of the subject and predicate device is included below in Table 1 and additional detailed subject information can be found in Appendix A in the engineering drawings. The Medline UNITE® IM Fibula Implants are within the currently marketed sizes, diameter and length of the identified predicate device.

Indications for Use

Medline UNITE® IM Fibula Implants are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Implants are intended for single use only.

Summary of Technological Characteristics

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline UNITE® IM FibulaImplants	Medline Cannulated Screws	Different
Product Photos	Image: Green screw	Image: Purple and blue screw	N/A
510(k) Reference	N/A	K130319	Different
Product Owner	Medline Industries, LP(previously Medline Industries,Inc.)	Medline Industries, Inc.	Same
Product Code	HWC	HWC	Same
Intended Use	Medline UNITE® IM FibulaImplants are indicated for use inbone reconstruction,osteotomies, arthrodesis, jointfusion, fracture repair, andfracture fixation of bonesappropriate for the size of thedevice. Implants are intendedfor single use only.	Medline Cannulated Screws areindicated for use in bonereconstruction, osteotomies,arthrodesis, joint fusion,fracture repair, and fracturefixation of bones appropriate forthe size of the device. Screwsare intended for single use only.	Same
Regulation Number	21 CFR 888.3040	21 CFR 888.3040	Same
Materials	Titanium Alloy	Titanium Alloy	Same
Sizes	3.7/4.0 x 65mm3.7/4.0 x 70mm3.7/4.0 x 75mm3.7/4.0 x 80mm3.7/4.0 x 85mm3.7/4.0 x 90mm	Ø2.0 x 10-24mmØ2.5 x 10-40mmØ3.0 x 10-40mmØ3.5 x 12-50mmØ4.0 x 14-50mmØ4.5 x 14-70mm	Different

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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Medline Industries, LP Three Lakes Drive Northfield, IL 60093

	3.7/4.0 x 95mm3.7/4.0 x 100mm3.7/4.0 x 110mm3.7/4.0 x 120mm3.7/4.0 x 130mm3.7/4.0 x 140mm3.7/4.0 x 150mm	Ø6.5 x 40-130mmØ7.5 x 40-130mm
Design Feature	Torx drive mechanismSelf-drilling and self-tapping	Torx drive mechanismSelf-drilling and self-tapping	Same
Prescription vs. OTC	Prescription	Prescription	Same
Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile	Same
Single Use vs. Reusable	Single Use	Single Use	Same

Summary of Non-Clinical Testing

The subject Medline UNITE® IM Fibula Implants do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). Analysis was conducted to further demonstrate substantial equivalence of the Medline UNITE® IM Fibula Implants to the predicate. Medline Cannulated Screws. A summary is present below with more information provided in the applicable sections.

Biocompatibility Testing

The Medline UNITE® IM Fibula Implants are manufactured from titanium alloy conforming to ASTM F136 and 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, Medline UNITE® IM Fibula Implants, do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). An engineering analysis was performed to determine that the subject screws do not present a new worst-case for pullout force and torsional yield strength when compared to the predicate. Based on this analysis, the subject device, Medline UNITE® IM Fibula Implants, are substantially equivalent to the predicate, Medline Cannulated Screws.

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

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K220511

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Not applicable.

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, LP concludes that the Medline UNITE® IM Fibula Implants are substantially equivalent to the predicate device, Medline Cannulated Screws (K130319).

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.