GMK Sphere CR Tibial Inserts

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font. August 23, 2018 Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118 Re: K181635 Trade/Device Name: GMK Sphere CR Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 9, 2018 Received: July 10, 2018 Dear Chris Lussier: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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, Peter G. Allen -S 2018.08.23 12:38:28 -04'00' - FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | K<br>1 | |----------------| | 8<br>1 | | ଦ୍ରହ୍ମ ବିଚିତ୍ର | | കുട്ടപ്പ | | 1 | | ਹੈ। | | 1 | Form Approved: ONB Alo. 0810-0120 ee PRA Statesment below xpiration Date: 06/30/2022 ЭЭЛУЯЭГ ИАМИН ОИА НТЈАЭН ТО ТИЭМТЯАЧЭО Food and Drug Administration # ndications for Use 510(k) Number (if known K181635 Device Name CMK Sphere Cruciate Retaining Tibial Insert Indications for Use (Describe) pone to seat and support the components. our stille fo and the since of interest for coments of the is is in is is in is is in is in internet consisted in and This knee replacement system is indicated in the following cases: - Avascular necrosis of femoral condyle Sweets painting and institutis, traint of arthuis, transmond artifits, transmond artifits on polyardina - Post traumatic loss of joint configuration - Primary implantation failure sy you əsinə sinfindən əsasə qalında da səs olunan mənasında mərkəzi və və sənələrin mənasında mərkəzi və mərkəzi və və və sənələrin mərkəzi və və və və sənələrin mərkəzi və və və ərin sayının sahəsindən ən qalında çəkinlər məşğul və bir və bərbəsinə ədədlər tipli ilə bir və bir və bir və bir məni used, an extension stem must be implanted. ure | Type of Use (Select one of both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| De Pro Pro Use (Far 21 CFR 21 CFR 801 Support D Over-The-Counter Use (21 CFFR 801 Suppert C) # CONTINUE ON A SEPARATE PAGE IF NEEDED Application 4 of 5 and to to to A noil suberes and to stremering of your seilede noitoes sing DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* A money and and and the are and of the stars of the specifically on on DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* -den time for this is stir ed to ge 79 hours per uding the DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* den time for this collection of tion is estimated to average 79 hours per response. including the DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* den time for this collection of information is estimated to average 79 hours per response, including the DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* rden time for this collection of information is estimated to average 79 hours per response, including the *DO NOT SEND YOUR COMPLETED FORM TO THE PRASTAFF EMAIL ADDRESS BELOW. urden time for this collection of information is estimated to average 79 hours per response, including the burden time for this collection of information is estimated to average 79 hours per response, including the to review instructions se ch existing data so ces gather and maintain the data ne ed and co plete and pribuları, şenodres neq sund et serine of belemites si noitseller sint not emit rebrud edit time to respenses and nishing bus sources, gories and manufactures date needed and come burden time for this collection of information is estimated to average 79 hours per response, including t e to review instructions, search existing data sources, gather and maintain the data needed and complet the ion g this estir te other a marka sama samina nebund sing published on series moitem in noitemoring on the of this information collection, including suggestions for reducing this burden, to: collection, including suggestions for reducing this burden, to: Department of Health and Human Services lepartment of Health and Human Services Department of Health and Human Service Food and Drug Administration Department of Health and Human Service Food and Drug Administration Food and Drug Administration Department of Health and Human Services Food and Drug Administration Department of Health and Human Service and Drug Administration of Chief Information Officer Office of Chief Information Officer a montal and production of painings tour si nosted a pris "losuods you year your and PRS.Sistif@fdb.hhs.goov Paperwork Reduction Act (PRA) Stat information unless it differ the currently valid OMB number. 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Department of Health and Human Servic {3}------------------------------------------------ # 510(k) Summary ### I. Submitter Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66 Contact Person: Stefano Baj, Regulatory Affairs Manager, Medacta International SA Date Prepared: June 20, 2018 ### II. Device | Device Proprietary Name: | GMK Sphere CR Tibial Inserts | |--------------------------|------------------------------------------------------------------------------------------------| | Common or Usual Name: | Tibial Inserts | | Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis. | | Primary Product Code: | JWH | | Regulation Number: | 21 CFR 888.3560 | | Device Classification | II | ### Predicate Device III. Substantial equivalence is claimed to the following devices: - GMK Sphere K121416, Medacta International SA; ● - GMK Sphere Extension - K140826, Medacta International SA; and - GMK Sphere Tibial Insert Flex K162035, Medacta International SA. ● ### IV. Device Description The GMK Sphere CR Tibial Inserts are a line extension to the GMK Sphere Total Knee System and are comprised of the following products: - Tibial insert fixed CR: Left and Right, Sizes 1-6, Thicknesses 10-11-12-13-14 mm, UHMWPE (ISO 5834-2) Type 1. {4}------------------------------------------------ The purpose of this submission is to introduce a new GMK Sphere insert design that does not require Posterior Cruciate Ligament (PCL) release. The introduction of the subject items does not require additional instrumentation needed during the surgical procedure (with exception of the specific CR trial tibial inserts) and does not alter the intended use or outcomes. The following components of the GMK Sphere have been cleared previously under K121416 and K140826 predicate device: - Femoral Component Left and Right, Sizes 1-7 Co-Cr-Mo (ISO 5832-4 Third Edition 2014-09-15 ● Implants for Surgery - Metallic Materials - Part 4: Cobalt-Chromium-Molybdenum Casting Alloy); - Femoral Component Left and Right, Sizes 1+ to 6+ (intermediate sizes) Co-Cr-Mo (ISO 5832-4 Third Edition 2014-09-15 Implants for Surgery - Metallic Materials - Part 4: Cobalt-Chromium-Molybdenum Casting Alloy); - . Tibial tray fixed cemented Left and Right, 4 intermediate sizes Co-Cr-Mo (ISO 5832-4 Third Edition 2014-09-15 Implants for Surgery - Metallic Materials - Part 4: Cobalt- Chromium-Molybdenum Casting Alloy); - Tibial Insert Fixed Flex, Left and Right, Sizes 1-6, 10mm -20mm UHMWPE (ISO 5834 2:2011 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms) Type 1, Ti6A15V (ISO 5832-3:1996 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy); - Tibial Insert Fixed Flex, Left and Right, Sizes 1-6, 11mm and 13mm UHMWPE (ISO 5834-● 2:2011 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms) Type 1, Ti6Al4V (ISO 5832-3:1996 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy; and - Instrumentation. ● The following components of the GMK Sphere have been cleared previously under the Medacta GMK Total Knee System: - Resurfacing patella Sizes 1-4 (K090988 and K113571); - Tibial tray fixed cemented Left and Right, Sizes 1-6 (K090988); and ● - . Primary extension stem Ø 11mm/ L 65mm (K090988) and L 30mm (K133630). ### V. Indications for Use The GMK Knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle ● - Post traumatic loss of joint configuration - Primary implantation failure ● {5}------------------------------------------------ Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semiconstrained liner is used, an extension stem must be implanted both on the fibial and on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted. ### VI. Comparison of Technological Characteristics The GMK Sphere CR Tibial Insert and the predicate devices share the following characteristics: - Indications for Use; ● - Sizes; - Materials; - Packaging, with exception of the screw, not included for the subject devices. The use of the inlay screw became optional with K162035; - Device Usage; ● - Shelf Life; and ● - Sterilization Method. ● The GMK Sphere CR Tibial Insert is technologically different from the predicate devices as follows: - Thickness is limited to 14 mm. Thicknesses 17 and 20mm are not available because implanting ● similar thicknesses requires a tibial resection too distal that doesn't allow retaining PCL ligament. - Specific cruciate retaining design: ● - 1. reduced medial anterior lip, as a consequence of the reduced risk of femoral anterior dislocation due to the presence of the PCL - reduced posterior congruency, thus being able to accommodate femoral posterior roll-2. back during flexion due to the presence of the PCL - 3. posterior opening for PCL, created to accommodate the ligament, avoiding impingement during flexo-extension motion. The posterior PCL medio-lateral opening lengths are the same as the already cleared GMK Primary CR inserts (K090988). Biocompatibility testing conducted on the predicate devices for the same material supports the biological safety of the GMK Sphere CR Tibial Inserts. Additional testing was deemed unnecessary. A review of the mechanical data indicates that the GMK Sphere CR Tibial Inserts are equivalent to devices currently cleared for use and are capable of withstanding expected in vivo loading without failure. The GMK Sphere CR was compared to the worst case predicate device in terms of fatigue, wear, and range of motion and it was determined that the GMK Sphere CR is not worst case. ### VII. Performance Data A review of the mechanical data on the subject and predicate that the additional cruciate retaining insert is equivalent to devices currently cleared for use and does not alter the intended surgical outcomes. The purpose of this submission is to introduce a new GMK Sphere insert design that does not {6}------------------------------------------------ require Posterior Cruciate Ligament (PCL) release. The introduction of the subject items does not require additional instrumentation needed during the surgical procedure, with exception of the specific CR trial tibial inserts. The new CR insert design introduction was evaluated by risk analysis to identify any new risks associated. Based on the risk analysis, additional tests have been performed in order to demonstrate that the new CR inserts are as safe as effective as the predicate devices. The GMK Sphere CR was tested for the following compared to the predicate devices: - Constraint measurements; - Contact pressures and areas; - Dynamic physiological loads; and ● - Range of Motion. ## VIII. Conclusion The information provided above supports that the GMK Sphere CR Tibial Inserts are as safe and effective as the predicate devices. The main purpose of the submission is to introduce a new GMK Sphere insert design that does not require Posterior Cruciate Ligament (PCL) release. The addition of the new cruciate retaining insert design and the thickness limitation to 14 mm does not raise any new questions of safety and effectiveness. Therefore, it is concluded that the GMK Sphere CR Tibial Inserts are substantially equivalent to the predicate devices. -----------------------This space intentionally left blank--------------------------------------------------------------------------------------------------------------------