Subject of this premarket notification is the EVOS Large Fragment Plating System. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking screws described in this premarket notification. It is comprised of a variety of locking and non-locking 4.5mm straight plates, 3.5mm and 4.5mm anatomical plates as well as previously cleared 3.5mm locking and non-locking screws and new 4.5mm locking and non-locking screws, 5.7mm cannulated locking screws, 6.5mm locking and nonlocking screws, and 6.7mm high-torque (osteopenia) screws.

AI/ML Overview

The provided text describes the EVOS Large Fragment Plating System, a medical device for bone fracture fixation. The document details the pre-clinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criterion	Reported Device Performance
Bending Performance (Static/Cantilever Bend Testing or Construct Fatigue Testing)	The subject plates should perform similar or superior to the predicate plates tested, when evaluated under the same conditions. (Identified through FEA as "worst case" plates)	Results determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
Locking Mechanism Performance (4.5mm Screws - Static Cantilever Bending and Fatigue)	The results should meet the acceptance criteria in that they were similar or superior (higher) than the predicates. (Evaluated through the threaded locking mechanism and variable angle locking holes)	The results met the acceptance criteria in that they were similar or superior (higher) than the predicates.
Torque to Failure Testing (4.5mm Bone Screws)	The static torsional performance of the EVOS screws should be similar to the static torsional performance of a previously cleared predicate device. (Following ASTM F543 guidelines)	The acceptance criterion was met in that the static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device.
Axial Pull-out Testing (4.5mm, 5.7mm, 6.5mm, 6.7mm Screws)	The subject screws should show similar or superior (higher) pull-out strength compared to the predicates OR meet the performance criteria from FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. (Following ASTM F543 guidelines)	The acceptance criterion was met in that the subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates or met the performance criteria from FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway.
Magnetic Resonance Imaging (MRI) Compatibility Testing	Compliant with FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.	Testing was conducted as per the FDA's guidance. (Results are implied to have met the criteria as there is no mention of failure)
Packaging Verification Testing	The product will not be damaged during shipment and will adequately maintain sterility post shipment.	The results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment.
Bacterial Endotoxin Testing	Met acceptable endotoxin limits as stated in specific FDA Guidance documents and ANSI/AAMI ST72.	Testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Biocompatibility Testing	(Implicitly, the device should be biocompatible as per relevant standards and guidance.)	EVOS Large Fragment Fracture Plating System Biocompatibility Testing conducted. (Results are implied to have met the criteria)

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state specific sample sizes for each mechanical test. Instead, it refers to evaluating "worst case plate designs" identified through Finite Element Analysis (FEA). While FEA itself is a computational method, the subsequent mechanical testing would involve a physical sample size. This information is a major gap in the provided text.
The data provenance is pre-clinical testing, meaning it was conducted in a laboratory setting, not on human subjects. There is no information regarding country of origin of the data provided in the FDA letter.
The testing is retrospective in the sense that it compares the new device to existing predicate devices already on the market.

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

This information is not applicable as the studies described are pre-clinical mechanical and material tests, not clinical studies involving human patients or expert interpretation of medical images. "Ground truth" in this context refers to established engineering standards (e.g., ASTM F543) and performance characteristics of predicate devices against which the new device's performance is measured.

4. Adjudication Method for the Test Set:

This information is not applicable for pre-clinical mechanical and material testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials involving human subjects where multiple experts evaluate outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted clinical decision support tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The EVOS Plating System is a surgical implant, not a diagnostic or AI-driven tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this is not applicable. The device is an orthopedic implant, not a software algorithm.

7. The Type of Ground Truth Used:

For the mechanical and material tests, the "ground truth" used for comparison falls into these categories:
- Predicate Device Performance: The primary ground truth is the established performance characteristics of the legally marketed predicate devices (e.g., Smith & Nephew Locking Bone Plate System (PERI-LOC)).
- Standardized Performance Criteria: For screws, specific FDA Guidance documents (e.g., "FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway") and international standards (e.g., ASTM F543, ANSI/AAMI ST72) serve as ground truth for acceptance.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of mechanical pre-clinical testing for a surgical implant. Training sets are used in machine learning and AI development. The Finite Element Analysis (FEA) performed could be considered a form of "computational modeling" that informs the physical testing, but it's not a "training set" in the AI sense.

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

This information is not applicable as there is no "training set." The performance targets for the device were established based on the characteristics of predicate devices and relevant industry/regulatory standards.

Summary

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November 16, 2020

Smith & Nephew, Inc. Thomas Fearnley Senior Regulatory Affairs Specialist 1450 E Brooks Rd Memphis, Tennessee 38116

Re: K201918

Trade/Device Name: EVOS Large Fragment 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. NDG Dated: September 1, 2020 Received: September 2, 2020

Dear Thomas Fearnley:

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) K201918

Device Name EVOS Large Fragment Plating System

Indications for Use (Describe)

The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

Type of Use (Select one or both, as applicable)
Commercial Use (e.g., Sales, Rentals)
Personal Use (e.g., Recreation)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	June 19, 2020
Name of Device:	EVOS Large Fragment Plating System
Common Name:	Bone Plates
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories
	21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS, HWC, NDG

Predicates

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew Locking Bone Plate System (PERI-LOC) Primary Predicate	K033669	December 10, 2003
Smith & Nephew, Inc.	EVOS Small Fragment Plating System Straight Plates and Screws	K162078	November 18, 2016
Smith & Nephew, Inc.	PERI-LOC Periarticular Locked Plating System for the Upper Extremity	K061352	June 8, 2006
Smith & Nephew, Inc.	PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories	K072818	November 19, 2007
Smith & Nephew, Inc.	PERI-LOC Periarticular Locked Plating System for Lower & Upper Extremity	K092015	July 30, 2009
Smith & Nephew, Inc.	Smith & Nephew Bone Plate System (TC-100)	K993106	December 09, 1999

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Device Description

Indications for Use

The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics. The subject devices include locking and non-locking plates. Screw holes in the locking plates can either be threaded holes or variable angle holes and the non-locking plates have non-threaded holes. The subject screws feature a hex drive and are similar to existing Smith & Nephew predicate screws with respect to threadform and major and minor diameter.

Summary of Pre-Clinical Testing

Finite element analysis (FEA) was conducted on the proposed plate designs to determine the . worst case plates for further mechanical testing. Plates were separated into groups for evaluation based upon similar designs or anatomical application.
. Bending performance was evaluated through static or cantilever bend testing or construct fatigue testing for the worst case plate designs identified through FEA. Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
Static cantilever bending and fatigue performance of the locking mechanism for the 4.5mm . screws were evaluated at a fixed angle through the threaded locking mechanism and variable angle locking holes and the results met the acceptance criteria in that they were similar or superior (higher) than the predicates.
Torque to failure testing for the proposed 4.5mm bone screws as the worst case was conducted following the guidelines of ASTM F543. The acceptance criterion was met in that the static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device.
Axial pull-out testing was conducted on the proposed 4.5mm, 5.7mm, 6.5mm and 6.7mm ● screws following the guidelines of ASTM F543. The acceptance criterion was met in that the subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates or met the performance criteria from FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway.
Magnetic resonance imaging (MRI) compatibility testing was conducted as per the FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.

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. Packaging verification testing was conducted for the proposed packaging configurations and the results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated . in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
EVOS Large Fragment Fracture Plating System Biocompatibility Testing ●

Conclusion

This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Large Fracture Plating System. Based on similarities to the predicate plating systems and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices.

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.