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Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented（MBF）
非セメント型半制動式肩関節用人工関節（金属/ポリマー） この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
20 件
直近 2025.03.26
37 件
0 件
1,570 件
分類情報
| Product Code | MBF |
|---|---|
| デバイス名 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented 非セメント型半制動式肩関節用人工関節（金属/ポリマー） この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 888.3670 |
| 審査区分 | 510(k)（市販前届出） |
| 医療専門分野 | 整形外科 |
| 定義 | － |
| フラグ | インプラント機器 |
| AI分析 | 本品は米国FDAの規制上クラスIIに分類される医療機器であり、市販前届出（510(k)）による審査区分が適用されます。クラスIIは中程度のリスクを有する機器に対する分類であり、既存の同等品（predicate device）との実質的同等性を示すことで市販が可能となる点が特徴です。これはクラスIIIの機器に要求される市販前承認（PMA）のような、臨床データを含む詳細な安全性・有効性の証明までは求められない審査区分です。 米国市場での動向 本製品コードの510(k)は累計約40件、直近5年でも約10件の届出があり、参入企業数は15社となっています。PMAでの承認はありません。不具事報告は累計約1,600件で、大半が傷害（Injury）に区分され、死亡報告は2件、主な問題としてBreak、Device Dislodged or Dislocated、Loosening of Implant Not Related to Bone-Ingrowthが挙げられています。回収は累計約20件で、クラスIIが18件、クラスIIIが1件、クラスIは確認されておらず、最新の回収は2025年3月に開始されています。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 整形用品 | 全人工肩関節クラスⅢ | 33 | 11 | 36.08 億円/年 | +6.9% | 5.76 万円/個 | 27.4% |
| 2 | 整形用品 | 人工肩関節上腕骨コンポーネントクラスⅢ | 34 | 9 | 23.3 億円/年 | +25.5% | 13.4 万円/個 | 0.0% |
| 3 | 整形用品 | 人工肩関節関節窩コンポーネントクラスⅢ | 18 | 9 | 8.58 億円/年 | +31.5% | 6.42 万円/個 | 0.0% |
| 4 | 整形用品 | 人工肘関節上腕骨コンポーネントクラスⅢ | — | — | — | — | — | — |
| 5 | 整形用品 | 全人工手関節クラスⅢ | 1 | 1 | — | — | — | — |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 20 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1403-2025 MBF | クラス II | 2025.03.03 | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY | Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement. | 対応中 |
| Z-0726-2024 MBF | クラス II | 2023.08.29 | Limacorporate S.p.A | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position. | 対応中 |
| Z-2010-2023 MBF | クラス II | 2023.05.30 | Limacorporate S.p.A | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | 対応中 |
| Z-2009-2023 MBF | クラス II | 2023.05.30 | Limacorporate S.p.A | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | 対応中 |
| Z-1317-2023 MBF | クラス II | 2023.02.21 | Limacorporate S.p.A | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation. | 対応中 |
| Z-0677-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0676-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0675-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0674-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0673-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0672-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0671-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-0670-2022 MBF | クラス II | 2022.01.07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. | 終了 |
| Z-1543-2020 MBF | クラス II | 2020.02.17 | Biomet, Inc. | A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. | 終了 |
| Z-0533-2020 MBF | クラス II | 2019.08.21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 終了 |
| Z-0527-2020 MBF | クラス II | 2019.08.21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 終了 |
| Z-0591-2019 MBF | クラス II | 2018.10.10 | Zimmer Biomet, Inc. | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available. | 終了 |
| Z-0299-2018 MBF | クラス II | 2017.06.05 | Zimmer Biomet, Inc. | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 終了 |
| Z-1755-2015 MBF | クラス III（軽微） | 2015.04.16 | Biomet, Inc. | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 終了 |
| Z-1992-2009 MBF | － | － | － | － | － |
510(k)（市販前届出）
全 37 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | 2026.04.13 | 通常（Traditional） | |
| 2 | K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025.08.11 | 通常（Traditional） | |
| 3 | K250848 | Identity Shoulder System | Zimmer, Inc. | 2025.07.02 | 通常（Traditional） | |
| 4 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024.06.12 | 通常（Traditional） | |
| 5 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024.01.11 | 通常（Traditional） | |
| 6 | K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023.12.21 | 通常（Traditional） | |
| 7 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023.11.13 | 通常（Traditional） | |
| 8 | K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | 2023.07.21 | 通常（Traditional） | |
| 9 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023.02.03 | 通常（Traditional） | |
| 10 | K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022.10.06 | 通常（Traditional） | |
| 11 | K213856 | Identity Shoulder System | Zimmer, Inc. | 2022.09.15 | 通常（Traditional） | |
| 12 | K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022.06.08 | 通常（Traditional） | |
| 13 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022.05.19 | 通常（Traditional） | |
| 14 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021.05.20 | 通常（Traditional） | |
| 15 | K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020.12.17 | 通常（Traditional） | |
| 16 | K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020.10.28 | 通常（Traditional） | |
| 17 | K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019.10.10 | 通常（Traditional） | |
| 18 | K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | 2019.01.22 | 通常（Traditional） | |
| 19 | K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | 2018.10.23 | 通常（Traditional） | |
| 20 | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017.06.29 | 通常（Traditional） |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
この product code の PMA 情報はありません。
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.07
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。