[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KWM":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":110,"syncDates":119,"translation":126,"marketSummary":132,"recalls":148,"k510s":150,"pmas":176},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},689,"KWM","Prosthesis, Wrist, Semi-Constrained","2","888.3800","OR","Orthopedic","1","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":18,"fei_number":25,"registration_number":27},[19,20,21,22,23,24],"K803031","K801157","K790774","K800602","K872502","K880156",[26],"3007289093",[26],"Y","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:49.029844+00:00",0,null,6,25,[],[39,47,54,61,68,75,82,90,96,103],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},620,"全人工手関節","Ⅲ","33705000",0.425,0.833141,0.0327869,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":33,"vector_similarity":52,"score":53},632,"人工橈骨手根関節橈骨・尺骨コンポーネント","35727000",0.345455,0.707044,0.031498,{"medical_device_id":55,"generic_name":56,"class_classification":42,"jmdn_code":57,"name_similarity":58,"definition_similarity":33,"vector_similarity":59,"score":60},626,"人工手関節手根骨コンポーネント","35663000",0.395833,0.700373,0.0306218,{"medical_device_id":62,"generic_name":63,"class_classification":42,"jmdn_code":64,"name_similarity":65,"definition_similarity":33,"vector_similarity":66,"score":67},636,"人工指関節","37845000",0.275,0.720351,0.0294624,{"medical_device_id":69,"generic_name":70,"class_classification":42,"jmdn_code":71,"name_similarity":72,"definition_similarity":33,"vector_similarity":73,"score":74},565,"人工骨頭","33704000",0.325,0.673339,0.0284455,{"medical_device_id":76,"generic_name":77,"class_classification":42,"jmdn_code":78,"name_similarity":79,"definition_similarity":33,"vector_similarity":80,"score":81},637,"人工関節セット","38158000",0.309524,0.681585,0.0282587,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":33,"vector_similarity":88,"score":89},4316,"人工装具ドライバ","Ⅰ","32865000",0.268293,0.674648,0.0261449,{"medical_device_id":91,"generic_name":92,"class_classification":42,"jmdn_code":93,"name_similarity":87,"definition_similarity":33,"vector_similarity":94,"score":95},674,"筋肉用補綴材","35272000",0.654675,0.0241841,{"medical_device_id":97,"generic_name":98,"class_classification":42,"jmdn_code":99,"name_similarity":100,"definition_similarity":33,"vector_similarity":101,"score":102},582,"全人工肘関節","70496000",0.23913,0.70983,0.015873,{"medical_device_id":104,"generic_name":105,"class_classification":42,"jmdn_code":106,"name_similarity":107,"definition_similarity":33,"vector_similarity":108,"score":109},577,"全人工肩関節","35670000",0.25,0.706537,0.0153846,[111,115],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"JWJ","Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained",17,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"JWI","Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained",3,{"510k":120,"classification":121,"enforcement":122,"event":123,"pma":124,"warning_letter":125},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":127,"definition_ja":34,"commentary_ja":128,"model_name":129,"source_hash":130,"reviewed_by":34,"reviewed_at":34,"created_at":131,"updated_at":131},"半拘束型手関節人工関節","この機器は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）の対象です。クラスIIは中程度のリスクを有する医療機器を対象とする区分であり、既存の同等な機器との実質的同等性を示すことで市販が認められる制度である510(k)により審査されます。","claude-sonnet-5","96d40e18aff8a0197c0bdda9b88ffc27fc9481500e7a3a607e3641a4ff61b564","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":146,"model_name":129,"created_at":147,"updated_at":147},"本製品コードは510(k)による市販前届出区分で、累計6件の届出があり、5社が参入していますが、直近5年間の届出実績や回収の報告は確認されていません。不具合報告は累計約30件で、死亡例は確認されておらず、傷害の報告が大半を占め、不具合（Malfunction）に関する報告もみられます。直近5年間の報告は1件で、最新の報告は2023年5月となっています。",{"pma":135,"k510":136,"as_of":139,"events":140,"recalls":143,"top_problems":145},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":137,"applicants":138},"1988-02-17",5,"2026-08",{"death":33,"other":118,"total":36,"injury":114,"last5y":141,"malfunction":138,"latest_month":142},1,"2023-05",{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":144},[],[],"c43073869128d75ae840c33bc2dddaec6190485cd2128fdca9dcd769d2224294","2026-08-24T04:46:30.426153+00:00",{"items":149,"total":33},[],{"items":151,"total":35},[152,157,161,165,169,173],{"k_number":24,"device_name":153,"applicant":154,"decision_date":137,"clearance_type":155,"decision_code":156,"statement_or_summary":34},"VOLZ TOTAL WRIST PROSTHESIS","Biomet, Inc.","Traditional","SESE",{"k_number":23,"device_name":158,"applicant":159,"decision_date":160,"clearance_type":155,"decision_code":156,"statement_or_summary":34},"M.W.P. WRIST PROSTHESIS","Protek, Inc.","1987-07-23",{"k_number":19,"device_name":162,"applicant":163,"decision_date":164,"clearance_type":155,"decision_code":156,"statement_or_summary":34},"LAURE WRIST IMPLANT","Laure Prosthetics, Inc.","1982-06-29",{"k_number":22,"device_name":166,"applicant":167,"decision_date":168,"clearance_type":155,"decision_code":156,"statement_or_summary":34},"TALEISNIK TOTAL WRIST PROSTHESIS","Dow Corning Wright","1980-08-27",{"k_number":20,"device_name":170,"applicant":171,"decision_date":172,"clearance_type":155,"decision_code":156,"statement_or_summary":34},"WEBER-MAYO WRIST","Depuy, Inc.","1980-08-04",{"k_number":21,"device_name":174,"applicant":171,"decision_date":175,"clearance_type":155,"decision_code":156,"statement_or_summary":34},"LODA WRIST PROSTHESIS","1979-08-03",{"items":177,"total":33},[]]