EVOS Large Fragment Plating System

K201918 · Smith & Nephew, Inc. · HRS · Nov 16, 2020 · Orthopedic

Device Facts

Record IDK201918
Device NameEVOS Large Fragment Plating System
ApplicantSmith & Nephew, Inc.
Product CodeHRS · Orthopedic
Decision DateNov 16, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

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

Device Story

The EVOS Large Fragment Plating System consists of metallic bone plates and screws designed for the fixation of long bone fractures in adult patients. The system includes a variety of locking and non-locking 4.5mm straight plates, 3.5mm and 4.5mm anatomical plates, and various screws (3.5mm/4.5mm locking/non-locking, 5.7mm cannulated locking, 6.5mm locking/non-locking, and 6.7mm high-torque screws). The plates feature a screw-to-plate locking mechanism. The device is used by surgeons in a clinical setting to stabilize fractures, facilitating bone healing. The system is implanted during orthopedic surgery; the surgeon selects the appropriate plate and screw configuration based on the fracture site and patient anatomy. The device provides mechanical stability to the fractured bone, which is intended to support the patient's recovery process.

Clinical Evidence

Bench testing only. Evidence includes Finite Element Analysis (FEA) to identify worst-case designs, static and cantilever bending tests, construct fatigue testing, torque-to-failure testing (ASTM F543), and axial pull-out testing (ASTM F543). MRI compatibility was assessed per FDA guidance. Packaging verification, bacterial endotoxin testing (ANSI/AAMI ST72), and biocompatibility testing were also performed. Results demonstrated that the subject devices met acceptance criteria and performed similarly or superior to predicate devices.

Technological Characteristics

Metallic bone fixation system comprising plates and screws. Features screw-to-plate locking mechanisms (threaded or variable angle holes). Screws include hex drives. Materials and threadforms are similar to existing Smith & Nephew predicates. Testing conducted per ASTM F543 for torsional and pull-out performance. MRI compatible. Sterilization and packaging validated per FDA guidance.

Indications for Use

Indicated for adult patients for the fixation of long bone fractures.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | |---------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> <input checked="true" type="checkbox"/> <span>Commercial Use (e.g., Sales, Rentals)</span> </div> | | <div style="display:flex; align-items:center;"> <input type="checkbox"/> <span>Personal Use (e.g., Recreation)</span> </div> | X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # We are smith&nephew | Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 | |----------------------------------------------|---------------------------------------------------------------------------------------------------| | Date of Summary: | June 19, 2020 | | Name of Device: | EVOS Large Fragment Plating System | | Common Name: | Bone Plates | | Device Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories | | | 21 CFR 888.3040 Smooth or threaded metallic bone fixation<br>fastener | | Device Class: | Class II | | Panel Code: | Orthopaedics/87 | | Product Code: | HRS, HWC, NDG | # Predicates | Manufacturer | Description | Submission<br>Number | 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 | {4}------------------------------------------------ #### Device Description 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. ## 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. {5}------------------------------------------------ - . 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.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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