Journey II Unicompartmental Knee System

{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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue. February 11, 2019 Smith & Nephew, Inc. Amy Winegarden Regulatory Affairs Specialist II 7135 Goodlett Farms Parkway Cordova, Tennessee 38016 Re: K190085 Trade/Device Name: Journey II Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, KRR, NPJ Dated: January 16, 2019 Received: January 17, 2019 Dear Amy Winegarden: 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. 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You must comply with all the Act's {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Peter G. Allen -S. The date of the signature is 2019.02.11. The time of the signature is 18:54:56 -05'00'. 18:54:56 -05'00' FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K190085 Device Name JOURNEY II Unicompartmental Knee System #### Indications for Use (Describe) Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: - · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis: - · Correction of functional deformity; - · Revision procedures where other treatments or devices have failed; and - · Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. 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}------------------------------------------------ #### 510(K) SUMMARY | Submitted by: | Smith & Nephew, Inc.<br>Advanced Surgical Devices Division<br>7135 Goodlett Farms Parkway<br>Cordova, Tennessee 38016 | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date of Submission: | January 16, 2019 | | Contact Person: | Amy Winegarden, Regulatory Affairs Specialist II<br>T (412) 683-3844 x4135<br>M (412) 977-3427<br>F (412) 683-6447<br>Amy.Winegarden@Smith-Nephew.com | | Name of Device: | Smith & Nephew, Inc. JOURNEY II ◊ Unicompartmental Knee<br>System (Journey II UK) | | Common Name: | Knee Prosthesis | | Device Classification Name<br>and Reference: | 21 CFR 888.3520 Knee joint femorotibial metal/polymer<br>non-constrained cemented prosthesis | | Device Class: | Class II | | Panel Code: | Orthopaedics/87 | | Primary Product Code: | HSX | | Secondary Product Codes: | KRR, NPJ | | Predicate Device: | Primary Predicate: Journey II Uni Tibial Baseplate and<br>Insert—K152315<br><br>Secondary Predicate: Journey Uni Femoral Implant—<br>K102069<br><br>Tertiary Predicate- Zimmer Unicompartmental Knee<br>System—K160738<br><br>The predicate devices have not been subject to a design<br>related recall | ### Device Description: The subject of this Special 510(k) is the Journey II Unicompartmental Knee System (Journey II UK). The subject device is a unicondylar femoral and tibial implant set for treatment of unicompartmental osteoarthritis. The device is intended for appropriate unicondylar, medial or lateral, ACL and PCL preserving joint treatment (partial knee replacement). {4}------------------------------------------------ Components of this premarket notification consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instrumentation required will consist of femoral instruments used to make appropriate resections to prepare the femur for said implants and tibial instruments used to make a planar resection and implant preparation of the proximal tibia. The Journey II UK is a line extension of the Smith & Nephew Unicompartmental Knee line, incorporating previously cleared Smith & Nephew products. It contains design aspects of the existing Journey II Uni Tibial Baseplate and Inserts (S.E. K152315), the Journey Uni (S.E. K102069), and the ZUK (S.E. K160738). Femoral components are manufactured from Oxinium (Zr-2.5Nb), and feature ten sizes each in left medial/right lateral and right medial/left lateral side (hand) configurations. Tibial baseplates are manufactured from Titanium alloy (Ti-6Al-4V). They are available in: - . Ten sizes of implant with a medial primary / lateral secondary use offered in both left and right handedness (listed henceforth as "medial primary"), and - . Eight sizes of implant with a lateral primary / medial secondary use offered in both left and right handedness (listed henceforth as "lateral primary"). Each are expected to be used in its primarily listed compartment most often, but are designed for use in either medial or lateral compartments. Modular articular implants are manufactured from cross-linked polyethylene (XLPE) and are available in medial and lateral configurations for use with corresponding baseplate. They are symmetric for use in either right or left hand. ### Indications for Use Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, . or avascular necrosis. - Correction of functional deformity. - Revision procedures where other treatments or devices have failed. - . Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. ## Technological Characteristics The functionality, material, and indications for use of the subject device are identical to the predicates. The overall design consists of the same technological characteristics as predicate designs. Modifications include component sizing and fit, as well as combinations of features from the predicate implants. Features adopted from predicate devices encompass the interlock mechanism of the tibia components, articular surface geometries, and characteristics of the cemented surface of the components. These modifications do not affect the safety profile or fundamental scientific technology of the device. ### Performance Data Mechanical verification testing/analysis conducted for the subject device includes: {5}------------------------------------------------ - Unsupported Femoral Fatique Testing ● - . Unsupported Tibia Baseplate Fatique Testing - . Static testing of the insert locking mechanism - Fully Supported Fatigue/Cement Adhesion Testing . - Contact Area Analysis . - Biocompatibility - . Pyrogenicity A review of the results indicates that the Journev II UK implants are equivalent to the existing. legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device. 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. ### Substantial Equivalence Information The subiect device presented in this submission is substantially equivalent to the predicate Journey II Uni Tibial Baseplate and Inserts. The general functionality, indications for use, design features, operational principles, manufacturing processes, and materials are unchanged from the previously submitted devices. Predicate information is detailed in Table 5.1. A thorough discussion of substantial equivalence is presented in Section 9, Substantial Equivalence. | Manufacturer | Description | Submission<br>Number | Clearance Date | |----------------------|----------------------------------------------|----------------------|----------------| | Smith & Nephew, Inc. | Journey II Uni Tibia Base And<br>Insert | K152315 | 10/28/2015 | | Smith & Nephew, Inc. | Journey Uni Tibia Baseplates | K102069 | 10/05/2010 | | Smith & Nephew, Inc. | Zimmer Unicompartmental<br>Knee System (ZUK) | K160738 | 06/15/2016 | Table 5.1: Substantially Equivalent Predicates to the Journey II UK ### Conclusion As previously noted, this special 510(k) Premarket Notification is being submitted to request clearance for Journey II UK. The subject device is as safe and effective and performs as well as the predicate devices. Based on the similarities to the predicate devices and a review of the mechanical testing performed the subject device is substantially equivalent to the identified commercially available predicate devices.