Smith and Nephew Legion Hinge Knee System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. July 28, 2015 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Smith & Nephew Incorporated Ms. Allison Chan Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016 Re: K151118 Trade/Device Name: Smith and Nephew Legion Hinge Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: April 24, 2015 Received: April 30, 2015 Dear Ms. Chan: 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. 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 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); good manufacturing practice requirements as set forth in the {1}------------------------------------------------ Page 2 - Ms. Allison Chan quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ (N . {3}------------------------------------------------ | Submitted by: | | | | We are smith&nephew<br>510(k) Summary<br>Legion Hinge Knee<br>Smith & Nephew, Inc.<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 | |----------------------------------------------|------------------------------------------------------------------------------------------|--|--|-----------------------------------------------------------------------------------------------------------------------------------------| | Date of Summary: | July 24, 2015 | | | | | Contact Person and Address: | Allison Chan<br>Regulatory Affairs Specialist<br>T 901-399-1098<br>F 901-566-7022 | | | | | Name of Device: | Smith & Nephew, Inc. Legion Hinge Knee System | | | | | Common Name: | Total Knee Joint | | | | | Device Classification Name and<br>Reference: | 21 CFR 888.3510 Knee joint femorotibial metal/polymer<br>constrained cemented prosthesis | | | | | Device Class: | Class II | | | | | Panel Code: | Orthopaedics/87 | | | | | Product Code: | KRO | | | | #### Device Description Subject of this premarket notification is a material change to the femoral component and tibial trav in the Legion Hinge Knee System and design changes to the femoral component and axle. The Legion Hinge Knee System is used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss possibility including the insertion points of the collateral ligaments or patella tendon, or comminuted fractures of the proximal tibial or distal femur. Components of this premarket notification include the following components: - The femoral components manufactured from oxidized zirconium allov . (OXINIUM). - Design changes to the femoral component and axle ● - Tibial tray manufactured from Titanium alloy (Ti-6Al-4V). ● # Intended Use The Smith & Nephew Legion Hinge Knee System is indicated for: - 1. Rheumatoid arthritis. - 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. - 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. - 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. - 5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are incompetent. - 6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral {4}------------------------------------------------ ligaments (i.e. medial collateral and/or lateral ligament) are absent or incompetent. The Legion Hinge Knee System is for Cemented Use Only. ## Comparison of Technological Characteristics with the Predicate Device The Legion Hinge Knee System is substantially equivalent in design and fundamental scientific technology to the defined predicate device and does not raise any new issues of safety and efficacy. At a high level, the subject and predicate devices are based on the following same technological elements - Design-same articular geometry - Used as a total knee joint replacement . - Size range . - Use only with cement and single use . The following technological differences exist between the subject and predicate devices - . Use of OXINIUM femoral components - Use of Titanium alloy tibial tray . - Design change in the femoral component and axle . ### Performance Data The following performance data was provided in support of the substantial equivalence determination - Fatigue Testing of OXINIUM Hinge Knee with hyperextension and Varus-● Valqus Loading - Anterior/Posterior Static Shear Testing ● - Construct Fatigue Testing of the OXINIUM Legion Hinge Knee at 30° Flexion. ● - . Torque to Failure Evaluation of the OXINIUM Legion Hinge Guided Motion Lock Screw #### Substantial Equivalence Information The substantial equivalence of the Legion Hinge Knee is based on similarities in function, intended use, indications for use, overall design to the predicate systems listed in the following table. #### Table 5.1: Substantially Equivalent Predicates to the Legion Hinge Knee | Design Aspect<br>Reviewed | Legion Hinge Knee | Legion Hinge Knee | Legion Revision | |---------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------| | 510(k) Number | Subject 510(k) | K081111 | K043440 | | Manufacturer | Smith & Nephew | Smith & Nephew | Smith & Nephew | | Similar Indications for<br>Use | Yes | Yes | Yes | | Similar Sterilization<br>Methods | Yes | Yes | Yes | | Femoral Component<br>Size Offering Configuration Assembled or Stand-alone | Femoral<br>Component Yes Yes Assembly Configuration | Femoral Component Yes Yes Assembly and stand-alone | Femoral Component No Yes Stand-alone Configuration | {5}------------------------------------------------ | Design Aspect<br>Reviewed | Legion Hinge Knee | Legion Hinge Knee | Legion Revision | |---------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------|---------------------------------------------------| | Material Design | only<br>(OXINIUM<br>oxidized<br>zirconium) Internal<br>thread on one<br>end | configuration<br>CoCrMo Not threaded | OXINIUM<br>(oxidized<br>zirconium) Not Applicable | | Tibial Tray Size Offering Configuration Material | Tibial Tray Yes Yes Ti-6Al-4V | Tibial Tray Yes Yes CoCrMo | Tibial Tray No Yes Ti-6Al-4V | | Axle Size Offering Design | Axle Yes Threaded on<br>one end | Axle Yes Free floating | Not Applicable | | Compatible Knee<br>Systems | Yes | Not Applicable | Not Applicable | | Table 5.1: Substantially Equivalent Predicates to the Legion Hinqe Knee | | | | | |-------------------------------------------------------------------------|--|--|--|--| | | | | | | # Conclusion As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Legion Hinge Knee System. Based on review of the mechanical testing performed, the devices are substantially equivalent to above predicate systems.