[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PJY":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":124,"syncDates":125,"translation":132,"marketSummary":139,"recalls":161,"k510s":163,"pmas":165},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":36,"pma_count":38,"event_count":39},7012,"PJY","Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees","3","","Unknown","OR","2","The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":11,"gmp_exempt_flag":32,"third_party_flag":32,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":32,"medical_specialty_description":10,"summary_malfunction_reporting":33},{"fei_number":18,"pma_number":28,"registration_number":30},[19,20,21,22,23,24,25,26,27],"3011386779","3006017180","1825034","3013527433","3006151021","3013562441","3029890418","1721676","1450662",[29],"P190009",[19,20,21,22,23,24,25,26,27],"Y","N","Eligible","2026-08-18T05:52:53.878886+00:00","2026-08-24T02:00:47.808424+00:00",0,null,12,281,[],[42,51,59,67,76,84,92,100,109,117],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},573,"人工膝関節大腿骨コンポーネント","Ⅲ","35668000",0.170455,0.17316,0.72864,0.0307765,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},568,"人工股関節大腿骨コンポーネント","35666000",0.206897,0.163424,0.714435,0.0300921,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},628,"人工全耳小骨","35674000",0.156627,0.162304,0.716398,0.029236,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},4298,"臓器摘出用装具","Ⅰ","35654000",0.148148,0.185841,0.717971,0.0285714,{"medical_device_id":77,"generic_name":78,"class_classification":45,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},571,"片側置換型脛骨用人工膝関節","32836000",0.130435,0.19403,0.767286,0.0282982,{"medical_device_id":85,"generic_name":86,"class_classification":45,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},615,"全人工足関節","32837000",0.160494,0.119816,0.694218,0.025817,{"medical_device_id":93,"generic_name":94,"class_classification":45,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},679,"気管用補綴材","35458000",0.155844,0.131783,0.695782,0.0255788,{"medical_device_id":101,"generic_name":102,"class_classification":103,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},173,"吸収性ヘルニア・胸壁・腹壁用補綴材","Ⅳ","70433004",0.132075,0.140244,0.698685,0.0230159,{"medical_device_id":110,"generic_name":111,"class_classification":103,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},248,"吸収性人工腱","32869004",0.126437,0.175,0.741586,0.016129,{"medical_device_id":118,"generic_name":119,"class_classification":45,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":116},1138,"膵臓用瘻孔形成ドレナージステント","62611003",0.191011,0.127517,0.676982,[],{"510k":126,"classification":127,"enforcement":128,"event":129,"pma":130,"warning_letter":131},"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":133,"definition_ja":134,"commentary_ja":135,"model_name":136,"source_hash":137,"reviewed_by":37,"reviewed_at":37,"created_at":138,"updated_at":138},"経大腿切断者用骨統合式義肢","本装置は、義肢を骨に直接的に固定するための経皮的プロテーシス装置である。","本品は米国FDAの規制上クラスIIIに分類されており、市販前承認（PMA）の対象となります。クラスIIIは人体への侵襲性やリスクが高い、または有効性・安全性の実証データが十分でない機器に適用される区分であり、510(k)による市販前届出ではなく、より厳格な科学的根拠の提出と審査を要するPMAの手続きが必要とされます。","claude-sonnet-5","0dbdd194ff3a15c9d733479d9120052812cb751a6c5fb437ccd5015951404a5b","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":140,"stats":141,"stats_hash":159,"model_name":136,"created_at":160,"updated_at":160},"本品はPMAで承認されており、本承認1件に加え一部変更承認が約10件あり、直近では2026年4月に判定が行われています。不具合報告は累計で約280件に上り、死亡1件、傷害が約160件と、死亡・傷害の割合が高くなっています。主な問題としては、Detachment of Device or Device Component（デバイスまたは部品の脱離）、Mechanical Problem（機械的問題）、Fracture（破損）が挙げられています。なお、回収については累計・直近5年とも報告は確認されていません。",{"pma":142,"k510":146,"as_of":147,"events":148,"recalls":153,"top_problems":155},{"latest":143,"originals":144,"supplements":145},"2026-04-15",1,11,{"total":36,"last5y":36,"latest":37,"applicants":36},"2026-08",{"death":144,"other":36,"total":39,"injury":149,"last5y":150,"malfunction":151,"latest_month":152},156,224,124,"2026-07",{"total":36,"last5y":36,"latest":37,"class_i":36,"class_ii":36,"class_iii":36,"top_root_causes":154},[],[156,157,158],"Detachment of Device or Device Component","Mechanical Problem","Fracture","49a908064a7704cb202fb35ff815399cb56bf89d278152cc73e98207d8d55527","2026-08-24T05:13:39.867404+00:00",{"items":162,"total":36},[],{"items":164,"total":36},[],{"items":166,"total":38},[167,171,174,177,181,185,188,191,194,198,202,204],{"pma_number":29,"supplement_number":168,"trade_name":169,"applicant":170,"decision_date":143},"S011","OPRA Implant System","Integrum AB",{"pma_number":29,"supplement_number":172,"trade_name":169,"applicant":170,"decision_date":173},"S010","2026-03-12",{"pma_number":29,"supplement_number":175,"trade_name":169,"applicant":170,"decision_date":176},"S012","2026-02-12",{"pma_number":29,"supplement_number":178,"trade_name":179,"applicant":170,"decision_date":180},"S006","OPRA Implant System, Abutment component","2025-11-20",{"pma_number":29,"supplement_number":182,"trade_name":183,"applicant":170,"decision_date":184},"S009","OPRA Implant System","2025-08-14",{"pma_number":29,"supplement_number":186,"trade_name":183,"applicant":170,"decision_date":187},"S007","2025-01-15",{"pma_number":29,"supplement_number":189,"trade_name":169,"applicant":170,"decision_date":190},"S005","2024-04-09",{"pma_number":29,"supplement_number":192,"trade_name":169,"applicant":170,"decision_date":193},"S004","2023-12-21",{"pma_number":29,"supplement_number":195,"trade_name":196,"applicant":170,"decision_date":197},"S003","OPRA System","2023-04-21",{"pma_number":29,"supplement_number":199,"trade_name":200,"applicant":170,"decision_date":201},"S002","OPRA System","2021-02-12",{"pma_number":29,"supplement_number":203,"trade_name":169,"applicant":170,"decision_date":201},"S001",{"pma_number":29,"supplement_number":9,"trade_name":169,"applicant":170,"decision_date":205},"2020-12-18"]