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FR 50709（1996年9月27日）に基づき、1996年12月26日までにPMAを提出することを求める。","この機器は、可動方向や可動域が構造的に制限された「拘束型」の設計を持つ、金属とポリマーを組み合わせた指関節用人工関節です。米国ではクラスIIIに分類されており、これは人体へのリスクが最も高いとされる区分であることを意味します。クラスIIIの機器は原則としてPMA（市販前承認）による審査が必要とされ、市販前届出（510(k)）よりも厳格な、有効性および安全性に関する詳細な科学的データの提出が求められます。","claude-sonnet-5","b4962bccb612faac60ad49029f6c9a8d064fb696bf83fb979f8e46a0da3f8b09","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":137,"stats":138,"stats_hash":155,"model_name":133,"created_at":156,"updated_at":156},"本製品はPMA(市販前承認)区分で、本承認1件と一部変更承認5件が確認されており、最新の判定は2016年8月となっています。不具合報告は累計約20件で、死亡報告は確認されておらず、傷害が約10件、不具合(Malfunction)が約7件で、主な問題としてDevice Appears to Trigger Rejection(拒絶反応の誘発)およびFracture(破損)が挙げられています。回収については累計件数、クラス別件数ともに確認されていません。",{"pma":139,"k510":143,"as_of":144,"events":145,"recalls":150,"top_problems":152},{"latest":140,"originals":141,"supplements":142},"2016-08-09",1,5,{"total":36,"last5y":36,"latest":37,"applicants":36},"2026-08",{"death":36,"other":36,"total":39,"injury":146,"last5y":147,"malfunction":148,"latest_month":149},11,9,7,"2024-03",{"total":36,"last5y":36,"latest":37,"class_i":36,"class_ii":36,"class_iii":36,"top_root_causes":151},[],[153,154],"Device Appears to Trigger Rejection","Fracture","33a6ff61a23282cb02371ff5a3d583ccc090e48416a589452f14133aa6b8c83f","2026-08-24T04:46:30.426153+00:00",{"items":158,"total":36},[],{"items":160,"total":36},[],{"items":162,"total":38},[163,167,171,174,178,180],{"pma_number":24,"supplement_number":164,"trade_name":165,"applicant":166,"decision_date":140},"S005","BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS","Stryker 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