[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OYR":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":105,"syncDates":106,"translation":113,"marketSummary":120,"recalls":133,"k510s":135,"pmas":137},{"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":14,"gmp_exempt_flag":15,"raw":16,"created_at":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":22,"event_count":24},6498,"OYR","Filler, Bone Void, Recombinant Platelet-Derived Growth Factor","N","","Unknown","OR","3","For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":11,"gmp_exempt_flag":8,"third_party_flag":8,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":12,"life_sustain_support_flag":18,"medical_specialty_description":10,"summary_malfunction_reporting":19},{},"Y","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:48.882786+00:00",0,null,1,[],[27,36,45,53,62,68,76,83,90,97],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":33,"vector_similarity":34,"score":35},2536,"電気骨折治療器","Ⅱ","35463000",0.207792,0.18314,0.656248,0.0313188,{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},319,"植込み型骨電気刺激癒合推進装置","Ⅳ","70615000",0.126126,0.17094,0.629013,0.0252381,{"medical_device_id":46,"generic_name":47,"class_classification":39,"jmdn_code":48,"name_similarity":49,"definition_similarity":50,"vector_similarity":51,"score":52},1145,"ヒト脱灰骨基質使用吸収性骨再生用材料","47257004",0.101695,0.150407,0.681638,0.0163934,{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},623,"人工足関節距骨コンポーネント","Ⅲ","34108000",0.0444444,0.181818,0.677148,0.016129,{"medical_device_id":63,"generic_name":64,"class_classification":56,"jmdn_code":65,"name_similarity":59,"definition_similarity":66,"vector_similarity":67,"score":61},1037,"歯科用骨再建インプラント材","34006009",0.176471,0.619567,{"medical_device_id":69,"generic_name":70,"class_classification":56,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},625,"人工足関節脛骨コンポーネント","35662000",0.043956,0.18638,0.66367,0.015873,{"medical_device_id":77,"generic_name":78,"class_classification":30,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":75},2478,"超音波骨折治療器","18154000",0.192308,0.0929204,0.618032,{"medical_device_id":84,"generic_name":85,"class_classification":39,"jmdn_code":86,"name_similarity":22,"definition_similarity":87,"vector_similarity":88,"score":89},193,"ヒト自家移植組織","38745000",0.0970874,0.657309,0.015625,{"medical_device_id":91,"generic_name":92,"class_classification":39,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":89},1091,"ウシ由来弁付人工血管","46422014",0.180723,0.162963,0.612716,{"medical_device_id":98,"generic_name":99,"class_classification":39,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},260,"体内用吸収性合成・炭素繊維補綴材","33473204",0.0894309,0.154882,0.657136,0.0153846,[],{"510k":107,"classification":108,"enforcement":109,"event":110,"pma":111,"warning_letter":112},"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":114,"definition_ja":115,"commentary_ja":116,"model_name":117,"source_hash":118,"reviewed_by":23,"reviewed_at":23,"created_at":119,"updated_at":119},"組換え型血小板由来成長因子含有骨欠損補填材","脛距関節癒合術、脛踵関節癒合術、距舟関節癒合術及び踵立方関節癒合術を含む、補助的な移植材料を必要とする後足部及び足関節の癒合術において、自家骨移植の代替として使用するためのものである。","本品は米国FDAにおいて正式なデバイスクラス（クラスI・II・III）が付与されておらず、「分類対象外（Not classified）」として扱われています。そのため市販に際しては、通常の510(k)による市販前届出やPMAによる市販前承認といった標準化された審査区分があらかじめ定まっておらず、FDAの機器評価部門（ODE）への個別の照会（Contact ODE）を通じて規制上の取扱いを確認する必要があります。","claude-sonnet-5","381cd8914308ee6691bc9591327c08a3540f505083d741ff2c3897288aabe6c3","2026-08-24T02:26:34.466715+00:00",{"product_code":6,"summary_ja":121,"stats":122,"stats_hash":131,"model_name":117,"created_at":132,"updated_at":132},"本製品コードでは、510(k)および PMA の承認・届出実績は確認されていません。不具合報告は累計で1件のみで、傷害report(Injury)として報告されており、死亡や不具合(Malfunction)としての報告は確認されていません。最新の報告は2016年11月で、直近5年間の報告はありません。回収についても、クラスI・II・IIIいずれも累計0件で、回収実績は確認されていません。",{"pma":123,"k510":124,"as_of":125,"events":126,"recalls":128,"top_problems":130},{"latest":23,"originals":22,"supplements":22},{"total":22,"last5y":22,"latest":23,"applicants":22},"2026-08",{"death":22,"other":22,"total":24,"injury":24,"last5y":22,"malfunction":22,"latest_month":127},"2016-11",{"total":22,"last5y":22,"latest":23,"class_i":22,"class_ii":22,"class_iii":22,"top_root_causes":129},[],[],"2ed288c3e454530c95f44e562f8020aea54d0e82be94a92bc4850be5e06eaef6","2026-08-24T05:07:49.137996+00:00",{"items":134,"total":22},[],{"items":136,"total":22},[],{"items":138,"total":22},[]]