Anatomic Total Knee System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 19, 2017 Amplitude Mireille Lemery Director, Quality and Regulatory Affairs 11 Cours Jacques Offenbach Valence, FR 26000 France Re: K161414 Trade/Device Name: Anatomic Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 16, 2016 Received: December 19, 2016 Dear Mireille Lemery: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161414 Device Name ANATOMIC® Total Knee System Indications for Use (Describe) The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; - Post-traumatic loss of knee joint configuration and function; - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; - Revision of previous unsuccessful knee replacement or other procedure. The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only. Type of Use (Select one or both, as applicable) 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. 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Below the "A" is the word "AMPLITUDE" in black, with a small degree symbol to the right of the word. # 510(k) Summary of Safety and Effectiveness Information Traditional 510(k) Premarket - ANATOMIC® Total Knee System Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Date prepared: December 16th, 2016 | Assigned 510(k) number: | K161414 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Company: | AMPLITUDE<br>11, cours Jacques Offenbach, Zone Mozart 2<br>26000 Valence, FRANCE<br>Phone: +33 4 75 81 34 95<br>Fax: +33 4 75 41 41 78 | | Contact: | Mireille LEMERY | | Trade/Proprietary Name: | ANATOMIC® Total Knee System | | Classification Name: | Knee Prosthesis | | Classification/Product Code: | 21 CFR 888.3560, Class II, Product Code JWH | | Predicate Devices: | Scorpio® NRG® Knee, Howmedica Osteonics Corp<br>K030978, K042343, K071991<br>Freedom® Total Knee System, Maxx Orthopedics<br>Inc. K082019, K090411 | #### Service Client France Porte du Grand Lyon 01700 Neyron - France Tél : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18 ## 1. Device Description The ANATOMIC® Total Knee System belongs to the category of sliding posterior-stabilized total knee prostheses (PS, posterior-cruciate substituting). The ANATOMIC® Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral implant, a tibial implant and a patellar implant. The tibial implant consists of two components: tibial insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant. Export Customer Service 11, cours Jacques Offenbach Zone Mozart 2 26000 Valence - France Tél : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42 E-mail : amplitude@amplitude-ortho.com {4}------------------------------------------------ The femoral implant comes in right and left versions and in various sizes. The tibial baseplate and tibial insert are symmetrical and can be used both for right and left sides. The tibial baseplate comes in various sizes. The tibial insert is available in various sizes and thicknesses. The nominal size of the insert includes the thickness of the tibial baseplate. The standard keel (supplied in the tibial baseplate packaging) must be mounted and blocked on the implant by the surgeon before implantation. The components are for cemented used only. The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation. #### 2. Intended Use The ANATOMIC® Total Knee System is intended for replacement of the knee joint to reduce pain and restore knee function in comparison with preoperative status. #### 3. Indications for use The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of: - -Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; - -Post-traumatic loss of knee joint configuration and function; - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; - Revision of previous unsuccessful knee replacement or other procedure. - The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only. #### Summary of technological characteristics 4. | | Table 1: Main features comparison | | |--|-----------------------------------|--| |--|-----------------------------------|--| | Service Client France<br>Porte du Grand Lyon<br>01700 Neyron - France<br>Tél: +33 (0)4 37 85 19 19<br>Fax: +33 (0)4 37 85 19 18 | MATERIALS | Femoral<br>implant | ANATOMIC® Total<br>Knee System | Scorpio® NRG®<br>Knee | Freedom® Total<br>Knee System | Substantial<br>equivalence? | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------| | Export Customer Service<br>11, cours Jacques Offenbach<br>Zone Mozart 2<br>26000 Valence - France<br>Tél: +33 (0)4 75 41 87 41<br>Fax: +33 (0)4 75 41 87 42 | | Tibial<br>baseplate | CoCr<br>ISO 5832-4 | CoCr<br>ASTM F75 | CoCr<br>ASTM F75 | YES | | | | Tibial<br>insert | CoCr<br>ISO 5832-4 | CoCr<br>ASTM F75 | CoCr<br>ASTM F75 | YES | | | | Tibial<br>insert | UHMW-PE<br>ISO 5834-2 | UHMW-PE<br>ASTM F648 | UHMW-PE<br>ASTM F648 | YES | | | | Patellar<br>implant | UHMW-PE<br>ISO 5834-2 | UHMW-PE<br>ASTM F648 | UHMW-PE<br>ASTM F648 | YES | | | | Employed<br>technology | Posterior Stabilized | Posterior Stabilized | Posterior Stabilized | YES | | | | Anchoring system | Cemented | Cemented | Cemented | YES | | | Intended Use | Total Knee<br>Replacement | Total Knee<br>Replacement | Total Knee<br>Replacement | YES | | | | Sterilization<br>method | Gamma sterilization | Gamma sterilization | Gamma sterilization | YES | | | | Maximum flexion | High flexion = 130°<br>max | High flexion = 130°<br>max | High flexion = 155°<br>max | YES | | | | <b>Femoral component features</b> | | | | | | | | Model | 9 sizes | 9 sizes | 8 sizes | YES | | | | Dimensions | AP from 49.83 to<br>72.86 mm<br>ML 56 from to 76.7<br>mm | AP from 51 to 75<br>mm<br>ML from 57 to 82<br>mm | AP from 51 to 74<br>mm<br>ML 54 from to 78<br>mm | YES | | | | Anchoring system | Cage's surfaces<br>have negative<br>macrostructure<br>grooves type and<br>cones with a depth<br>of 0.5 mm as well<br>as positive<br>macrostructures<br>pyramid type with a<br>height of 0.5 mm<br>The surface in<br>contact with bone<br>cement is shot-<br>blasted | Wafle structures with<br>a depth of 0.6 mm<br>The surface in<br>contact with bone<br>cement is shot-<br>blasted | Groove depth 0.8<br>mm<br>The surface in<br>contact with bone<br>cement is shot-<br>blasted | YES | | | | Radius of<br>curvature | Single radius of<br>curvature from 0°<br>to 100° flexion | Single radius of<br>curvature from 0° to<br>95° flexion | Single radius of<br>curvature from 15°<br>to 120° | YES | | | | <b>Insert component features</b> | | | | | | | | Model | 9 sizes x 6<br>thickness | 5 sizes x 7 thickness | 8 sizes | YES | | | | Thickness | Thickness: 10, 12,<br>14, 16, 18 and 20<br>mm with Tibial Tray<br>Minimum<br>Polyethylene<br>Thickness: 6.8<br>without Tibial Tray | Thickness: 8, 10, 12,<br>15, 18, 21, 24 mm<br>with Tibial Tray<br>Minimum<br>Polyethylene<br>Thickness: 6 without<br>Tibial Tray | N/K | YES | | | | Insert minimum<br>thickness (mm) | 6.9 +/-0.1 mm | 6 mm, tolerance<br>unknown | N/K | YES | | | Service Client France<br>Porte du Grand Lyon<br>01700 Neyron - France<br>Tél : +33 (0)4 37 85 19 19<br>Fax : +33 (0)4 37 85 19 18<br><br>Export Customer Service<br>11, cours Jacques Offenbach<br>Zone Mozart 2<br>26000 Valence - France<br>Tél : +33 (0)4 75 41 87 41<br>Fax : +33 (0)4 75 41 87 42 | The anchoring<br>system of the<br>insert onto the<br>tibial baseplate | Peripheral locks at<br>six places (two<br>anterior clips,<br>posteromedial,<br>posterolateral,<br>lateral and medial<br>dovetails) | 2 posterior<br>undercuts<br>1 anterior wire<br>Peripheral lip | Peripheral locks at<br>five places (anterior,<br>posteromedial,<br>posterolateral,<br>lateral and medial<br>locking) | YES | | | | <b>Tibial component features</b> | | | | | | | | Model | 9 sizes | 8 sizes | 8 sizes | YES | | | | Dimensions | AP from 39.09 to<br>57.31 mm | AP from 40 to 58<br>mm | AP from 40 to 54<br>mm | YES | | E-mail : amplitude@amplitude-ortho.com {5}------------------------------------------------ E-mail : amplitude@amplitude-ortho.com Internet : www.amplitude-ortho.com {6}------------------------------------------------ | | ML from 60 to 88<br>mm | ML from 61 to 88<br>mm | ML from 59 to 78<br>mm | | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------|-----| | Tibial tray<br>thickness (mm) | 3 mm | 2.5 mm | 3.3 mm | YES | | Stem length | 41 mm | 30 to 40 mm | N/K | YES | | Surface aspect | Area in contact with<br>bone cement: shot-<br>blasted<br>Surface in contact<br>with tibial insert:<br>mirror polished | Shot-blasted | Shot-blasted | YES | | Patellar component features | | | | | | Model | 4 diameters | 6 models | 4 diameters | YES | | Dimension | 30, 33, 36 and 39<br>mm | 30, 32, 34, 36 and<br>38 mm | 25, 28, 31 and 34<br>mm | YES | | Thickness | 8 mm | 8 to 10 mm | Unknown | YES | | Patella fixation | Resurfacing patella<br>cemented with<br>three pegs | Resurfacing patella<br>are cemented with<br>three pegs and<br>grooves for cement. | All-poly resurfacing<br>patella cemented<br>with three pegs | YES | | Patella shape | Spherical dome<br>shape for<br>resurfacing patella | Spherical dome<br>shape for Universal<br>Patella | Spherical dome<br>shape for<br>resurfacing patella | YES | | Manufacturer | Amplitude | Howmedica<br>Osteonics Corp. | Maxx Orthopedics,<br>Inc. | | The product subject of this premarket notification is substantially equivalent in design and functionality to the Scorpio® NRG® Knee (K030978) and Freedom® Total Knee System (K082019). ### 5. Non clinical testing Functional testing was conducted in compliance with the FDA Guidance Class II/Special Controls Guidance Document Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003. Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence: - Tibial Baseplate fatique test - - Insert (post) fatigue test - - Wear test - - - Range of Motion - - Constraints Femoro-Tibial - - Constraints Patello-Femoral - - Contact Area/ Stress Femoro-Tibial - - Contact Area/ Stress Patello-Femoral - - Interlock Strength insert/ Baseplate E-mail : Service Client France Porte du Grand Lyon 01700 Neyron - France Tél : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18 # Export Customer Service 11, cours Jacques Offenbach Zone Mozart 2 26000 Valence - France Tél : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42 {7}------------------------------------------------ The UHMWPE material properties have been characterized according to test standards to demonstrate the conformity of the material. The galvanic effect on the corrosion of the assembly between the tibial baseplate and the standard keel has been assessed according to relevant standard to demonstrate the conformity of the assembly. MRI compatibility has not been evaluated for the ANATOMIC® Total Knee System. The results of these tests demonstrate the equivalence between the ANATOMIC® Total Knee System and the Scorpio® NRG® Knee (K030978) and Freedom® Total Knee System (K082019). #### 6. Substantial Equivalence Conclusion The proposed ANATOMIC® Total Knee System is believed to be substantially equivalent to the predicate devices with the same intended use and the same technological characteristics. Service Client France Porte du Grand Lyon 01700 Neyron - France Tél : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18 Export Customer Service 11, cours Jacques Offenbach Zone Mozart 2 26000 Valence - France Tél : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42 E-mail : amplitude@amplitude-ortho.com Internet : www.amplitude-ortho.com