KNEE IMPLANT TEST PLAN GENERATOR<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Normative Navigator Knee (#12)<\/legend>

• Disclaimer<\/span><\/li>
• Device Type<\/span><\/li>
• Component information<\/span><\/li>
• Regulatory details<\/span><\/li>
• Contact information<\/span><\/li><\/ul><\/div><\/span>

  (takes approx. 3 min)<\/p>\n

  To create a tailored test plan, please provide some information about your device.
  If you\u2019re unsure about a question, just leave it blank.<\/p>\n

  This generator is free to use. Please note that it is supplementary to the expertise of an RA professional<\/strong>.
  We strongly recommend discussing the generated plan with your targeted regulatory authority before submission.<\/p>\n

  All information you provide will be used solely<\/strong> for generating your test plan and will not<\/strong> be shared with third parties.
  If you require an NDA beforehand, please reach out via the contact form.<\/p>\n

  Once complete, you will receive a copy of your responses along with the generated test plan by email.<\/p><\/div>

  Previous<\/button>Next<\/button><\/div><\/div>

  Please specify the device type<\/h3><\/div>

  \u00a0<\/p>\n

  <\/p>\n

  Cruciate Retaining Knee Implant<\/strong><\/p>\n

  This design preserves the posterior cruciate ligament (PCL) to maintain more natural knee kinematics. It is often used when the patient\u2019s ligaments are healthy and stable.
  
  
  <\/p><\/div>

  Cruciate Retaining Knee Implant<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div>

  <\/p>\n

  \u00a0<\/p>\n

  Posterior Stabilised Knee Implant<\/strong><\/p>\n

  PS knees replace the function of the PCL with a cam-and-post mechanism in the implant, improving stability when the ligament is removed.<\/p><\/div>

  Posterior Stabilised Knee Implant<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div>

  <\/p>\n

  Ultra-Congruent \/ Medial-Pivot Knee Implant<\/strong><\/p>\n

  Ultra-congruent and medial-pivot femoral designs are alternatives to posterior-stabilised systems. Instead of using a post-cam mechanism, they rely on highly conforming tibial inserts to provide stability. Their goal is to better replicate natural knee kinematics.<\/p><\/div>

  Ultra-Congruent \/ Medial-Pivot Knee Implant<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div><\/div>

  \u00a0<\/p>\n

  <\/p>\n

  Hinged Knee Implant<\/strong><\/p>\n

  This design provides a mechanical hinge for stability in severe cases of instability, deformity, or bone loss. It is typically used in revision or complex surgeries.<\/p><\/div>

  Hinged Knee Implant<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div>

   <\/p>\n

  <\/p>\n

  Knee Augment \/ Cone \/ Flange<\/strong><\/p>\n

  There is a variety of accessory options that can be used alongside a knee replacement. Please select this option if you are developing such an implant.<\/p><\/div>

  Knee Augment \/ Cone \/ Flange<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div>

  <\/p>\n

   <\/p>\n

  Novel Implant<\/strong><\/p>\n

  We are excited to help you bring your innovative ideas to market. With our expertise in biomechanics, we design tailored procedures that meet your specific needs.<\/p><\/div>

  Novel Implant<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div><\/div>

  \u00a0<\/p>\n

  <\/p>\n

  Unicondylar Knee Implant<\/strong><\/p>\n

  This design resurfaces only the diseased compartment of the knee while preserving intact bone and ligaments to maintain natural joint kinematics. It is often used when arthritis is localized to a single area.<\/p><\/div>

  Unicondylar Knee<\/label><\/div>

  Select<\/span><\/label><\/div><\/div><\/div><\/div>

  <\/div>

  <\/div><\/div>

  Previous<\/button>Next<\/button><\/div><\/div>

  Please give us some additional information<\/h2><\/div>

  Femoral component<\/h3>\n

  Stemmed designs need careful evaluation of corrosion and fatigue properties.<\/p><\/div><\/div>

  Femoral component fixation<\/label><\/div>

  Cemented<\/span><\/label><\/div>

  Cementless<\/span><\/label><\/div><\/div><\/div>

  Femoral component material<\/label><\/div>

  Titanium<\/span><\/label><\/div>

  CoCrMo<\/span><\/label><\/div>

  Other<\/span><\/label><\/div><\/div><\/div>

  If other, please specify the femoral component material:<\/label><\/div>

  <\/div><\/div>

  Femoral component coatings<\/label><\/div>

  Titanium plasma spray<\/span><\/label><\/div>

  Hydroxyapatite<\/span><\/label><\/div>

  Other<\/span><\/label><\/div>

  None<\/span><\/label><\/div><\/div><\/div>

  If other, please specify the coating:<\/label><\/div>

  <\/div><\/div><\/div><\/div>

  Tibial Insert<\/h3>\n

  Specific tests may be needed for the locking mechanism.\u00a0<\/p><\/div><\/div>

  Tibial insert material<\/label><\/div>

  PE \/ UHMWPE<\/span><\/label><\/div>

  Other<\/span><\/label><\/div><\/div><\/div>

  If other, please specify the insert material:<\/label><\/div>

  <\/div><\/div>

  Tibial component design<\/label><\/div>

  <\/label> Mobile bearing<\/span><\/label><\/div>

  <\/label> Fixed bearing<\/span><\/label><\/div><\/div><\/div><\/div><\/div><\/div>

  Tibial Tray<\/h3>\n

   <\/p><\/div><\/div>

  Tibial Tray material<\/label><\/div>

  Titanium<\/span><\/label><\/div>

  CoCrMo<\/span><\/label><\/div>

  Stainless steel<\/span><\/label><\/div>

  Other<\/span><\/label><\/div><\/div><\/div>

  If other, please specify your material:<\/label><\/div>

  <\/div><\/div>

  Tibial Tray coatings<\/label><\/div>

  Titanium plasma spray<\/span><\/label><\/div>

  Hydroxyapatite<\/span><\/label><\/div>

  Other<\/span><\/label><\/div>

  None<\/span><\/label><\/div><\/div><\/div>

  Please describe your coating:<\/label><\/div>

  <\/div><\/div><\/div><\/div>

  Patella<\/h3>\n

   <\/p><\/div><\/div>

  Patella material<\/label><\/div>

  PE \/ UHMWPE<\/span><\/label><\/div>

  Other<\/span><\/label><\/div><\/div><\/div>

  If other, please specify your material:<\/label><\/div>

  <\/div><\/div>

  Patella design<\/label><\/div>

  onlay (on the bone)<\/span><\/label><\/div>

  inset (flush with the bone)<\/span><\/label><\/div><\/div><\/div>

  Patella shape<\/label><\/div>

  <\/label> dome<\/span><\/label><\/div>

  <\/label> modified dome<\/span><\/label><\/div>

  <\/label> offset dome<\/span><\/label><\/div>

  <\/label> cylindrical<\/span><\/label><\/div>

  <\/label> anatomical<\/span><\/label><\/div><\/div><\/div><\/div><\/div><\/div>

  Additional components<\/h3>\n

  Please specify any system components that may also need to be tested. This will allow us to develop a tailored testing plan for you.<\/p><\/div><\/div>

  Additional system components:<\/label><\/div>

  Stem<\/span><\/label><\/div>

  Augment<\/span><\/label><\/div>

  Cone<\/span><\/label><\/div>

  Flange<\/span><\/label><\/div>

  Other<\/span><\/label><\/div><\/div><\/div>

  Please specify any additional components:<\/label><\/div>

  <\/div><\/div>

  Are there any 3D-printed additional components?<\/label><\/div>

  Yes<\/span><\/label><\/div>

  No<\/span><\/label><\/div><\/div><\/div>

  Please specify any 3D-printed additional components:<\/label><\/div>

  <\/div><\/div><\/div><\/div>

  Previous<\/button>Next<\/button><\/div><\/div>

  Regulatory details<\/h3>\n

  Please let us know where you intend to market your device so we can take into account the specifics of the relevant approval processes.
  Our reports are accepted internationally and well-known by authorities like the FDA and PMDA.<\/p><\/div><\/div>

  Target Markets<\/label><\/div>

  United States (FDA)<\/span><\/label><\/div>

  Europe (MDR)<\/span><\/label><\/div>

  United Kingdom (BSI)<\/span><\/label><\/div>

  Japan (PMDA\/MHLW)<\/span><\/label><\/div>

  China (NMPA)<\/span><\/label><\/div>

  Australia (TGA)<\/span><\/label><\/div>

  Brazil (ANVISA)<\/span><\/label><\/div>

  India (CDSCO)<\/span><\/label><\/div>

  Other<\/span><\/label><\/div><\/div><\/div>

  Please specify:<\/label><\/div>

  <\/div><\/div>

  Do you already have data for a predicate device?<\/label><\/div>

  Yes<\/span><\/label><\/div>

  No<\/span><\/label><\/div><\/div><\/div>

  Please let us know your predicate test series number(s):<\/label><\/div>

  <\/div><\/div><\/div><\/div>

  Previous<\/button>Next<\/button><\/div><\/div>

  How may we contact you?<\/h2><\/div>

  Name<\/label><\/div>

  <\/div><\/div><\/div>

  Last Name<\/label><\/div>

  <\/div><\/div><\/div><\/div><\/div>

  Phone\/Mobile (optional, if you prefer to be called)<\/label><\/div>

  <\/div><\/div>

  I have tested with EndoLab before<\/label><\/div>

  Yes<\/span><\/label><\/div>

  No<\/span><\/label><\/div><\/div><\/div><\/div>

  Email<\/label><\/div>

  <\/div><\/div>

  Company<\/label><\/div>

  <\/div><\/div>

  I'm a consultant<\/label><\/div>

  Yes<\/span><\/label><\/div>

  No<\/span><\/label><\/div><\/div><\/div><\/div><\/div>

  Anything else we should know?<\/label><\/div>

  <\/textarea><\/div><\/div> <div class=\"ff-step-t-container ff-inner_submit_container ff-column-container ff_columns_total_2\">\n <div class=\"ff-t-cell ff-t-column-1\"><div class='step-nav ff_step_nav_last'><button style='float: left;' type='button' data-action='prev' class='ff-btn ff-btn-prev ff-btn-secondary' aria-label='Previous'>Previous<\/button><\/div><\/div>\n <div class=\"ff-t-cell ff-t-column-2\">\n <div class='ff-el-group ff-text-center ff_submit_btn_wrapper'><button type=\"submit\" class=\"ff-btn ff-btn-submit ff-btn-lg ff_btn_style\" aria-label=\"Propose Test Plan\">Propose Test Plan<\/button><\/div> <\/div>\n <\/div>\n <\/div><\/div><\/div>\n <\/fieldset><\/form><div id='fluentform_12_errors' class='ff-errors-in-stack ff_form_instance_12_1 ff-form-loading_errors ff_form_instance_12_1_errors'><\/div><\/div> <script type=\"text\/javascript\">\n window.fluent_form_ff_form_instance_12_1 = 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<\/script>\n <\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>KNEE IMPLANT TEST PLAN GENERATOR<\/p>","protected":false},"author":7,"featured_media":0,"parent":9956,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-10330","page","type-page","status-publish","hentry"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"Simon Kaddick","author_link":"https:\/\/endolab.org\/de\/author\/simon-kaddick\/"},"uagb_comment_info":0,"uagb_excerpt":"KNEE IMPLANT TEST PLAN 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