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再建後の高負荷条件下で十分な安定化及び固定を提供できる軟部組織及び骨を有し、かつb) 失敗したPIPプロテーゼの再置換を必要とする、又は関節軟骨の損傷若しくは破壊に続発する疼痛、可動域制限、若しくは関節亜脱臼\u002F脱臼を有する場合における、近位指節間（PIP）関節の関節形成術における使用のためのものである。","この製品は米国ではHDE（人道機器申請）という審査区分の対象とされています。HDEは対象となる疾患や状態の患者数が極めて少ない機器を対象とした制度であり、有効性の証明よりも安全性及び臨床的利益の蓋然性を中心に審査が行われる点で、通常の市販前届出（510(k)）や市販前承認（PMA）とは異なる規制上の枠組みとなっています。","claude-sonnet-5","1d3ec9cbb723933fac6cd5cb5e5c9a49f9d9895ea3a178d9a320cb3f1188c83c","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":134,"stats":135,"stats_hash":150,"model_name":130,"created_at":151,"updated_at":151},"市場実績としては510(k)およびPMAの届出・承認実績は確認されていません。不具合報告は累計約140件で、その大半が傷害（Injury）報告であり、不具合（Malfunction）報告は約10件、死亡報告は確認されていません。主な問題として、骨内方成長に関連しないインプラントの緩み（Loosening of Implant Not Related to Bone-Ingrowth）、位置のずれ（Migration）、機器の脱転・脱臼（Device Dislodged or Dislocated）が挙げられています。回収については、クラスI・II・IIIのいずれも確認されていません。",{"pma":136,"k510":137,"as_of":138,"events":139,"recalls":144,"top_problems":146},{"latest":33,"originals":32,"supplements":32},{"total":32,"last5y":32,"latest":33,"applicants":32},"2026-08",{"death":32,"other":32,"total":34,"injury":140,"last5y":141,"malfunction":142,"latest_month":143},127,131,11,"2026-03",{"total":32,"last5y":32,"latest":33,"class_i":32,"class_ii":32,"class_iii":32,"top_root_causes":145},[],[147,148,149],"Loosening of Implant Not Related to Bone-Ingrowth","Migration","Device Dislodged or Dislocated","4d5fdab35ef9bd207e80be0c618d6bce36559abfd7cd013083d6c611a83d3d52","2026-08-24T05:03:24.690751+00:00",{"items":153,"total":32},[],{"items":155,"total":32},[],{"items":157,"total":32},[]]