[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QZZ":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":38,"syncDates":39,"translation":46,"marketSummary":53,"recalls":68,"k510s":70,"pmas":88},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":35},6359,"QZZ","Limb And Joint Salvage Device With Coating For Bacteria Reduction","2","888.3900","OR","Orthopedic","1","A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":26,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":29},{"k_number":18,"fei_number":22,"registration_number":25},[19,20,21],"K252920","K253066","DEN210058",[23,24],"3032003630","3013450937",[23,24],"","Y","N","Ineligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:49.029844+00:00",0,null,3,66,[],[],[],{"510k":40,"classification":41,"enforcement":42,"event":43,"pma":44,"warning_letter":45},"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":47,"definition_ja":48,"commentary_ja":49,"model_name":50,"source_hash":51,"reviewed_by":33,"reviewed_at":33,"created_at":52,"updated_at":52},"細菌低減コーティング付き四肢・関節温存用インプラント","四級アンモニウム化合物コーティングを有する四肢・関節温存用装置とは、骨および関節置換のための、ポリマー製ベアリングを有する又は有しない金属製インプラントである。インプラントは、骨格が成熟した患者における四肢骨（骨全体、骨端部、骨幹端部又は骨幹部を含む）、又は四肢骨及びその周囲の関節の切除及び置換のためのものである。本装置は、当該装置に共有結合した四級アンモニウム化合物コーティングを含む。適用される場合、当該コーティングは、埋植前に装置表面上の微生物汚染を低減することを目的とする。本装置は、体内又は体表で作用する抗菌剤を含有せず、また本装置種別はコンビネーション製品を含まない。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象です。510(k)では、既に市販されている類似の機器（既存同等品）との実質的同等性を示すことにより、市販前承認（PMA）よりも簡略化された手続きで市販が認められます。","claude-sonnet-5","4d61a530517d0825bd5eba43e6fb53c1190662021d265d0c8ea73cb5f0f82912","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":54,"stats":55,"stats_hash":66,"model_name":50,"created_at":67,"updated_at":67},"本製品コードは510(k)による市販前届出品目で、累計届出件数は3件、参入企業数は2社、いずれも直近5年以内のもので、最新の判定は2026年6月です。不具合報告は累計約70件で、その大半が傷害（Injury）に分類され、死亡や不具合（Malfunction）の報告は確認されていません。最新の報告は2026年7月時点となっています。回収については累計件数0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":56,"k510":57,"as_of":60,"events":61,"recalls":63,"top_problems":65},{"latest":33,"originals":32,"supplements":32},{"total":34,"last5y":34,"latest":58,"applicants":59},"2026-06-08",2,"2026-08",{"death":32,"other":32,"total":35,"injury":35,"last5y":35,"malfunction":32,"latest_month":62},"2026-07",{"total":32,"last5y":32,"latest":33,"class_i":32,"class_ii":32,"class_iii":32,"top_root_causes":64},[],[],"33e9169ddeb709756a87d6bc071269631d788fd0f22cb67800a195104473bdbe","2026-08-24T05:22:13.607018+00:00",{"items":69,"total":32},[],{"items":71,"total":34},[72,78,82],{"k_number":20,"device_name":73,"applicant":74,"decision_date":58,"clearance_type":75,"decision_code":76,"statement_or_summary":77},"ELEOS™ with NanoCept® Technology Limb Salvage System","Onkos Surgical, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":79,"applicant":74,"decision_date":80,"clearance_type":81,"decision_code":76,"statement_or_summary":77},"ELEOS™ Limb Salvage System with NanoCept® Technology","2025-10-15","Special",{"k_number":21,"device_name":83,"applicant":84,"decision_date":85,"clearance_type":86,"decision_code":87,"statement_or_summary":33},"ELEOSx™ Limb Salvage System","Onkos Surgical","2024-04-05","Direct","DENG",{"items":89,"total":32},[]]