Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3350](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3350) → JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented # JDI · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented _Orthopedic · 21 CFR 888.3350 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI ## Overview - **Product Code:** JDI - **Device Name:** Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - **Regulation:** [21 CFR 888.3350](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3350) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 562) Showing 20 most recent of 562 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243571](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K243571.md) | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | Jul 31, 2025 | SESE | | [K240783](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K240783.md) | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | Oct 21, 2024 | SESE | | [K241716](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K241716.md) | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Aug 2, 2024 | SESE | | [K240418](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K240418.md) | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Apr 12, 2024 | SESE | | [K233261](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K233261.md) | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Dec 8, 2023 | SESE | | [K222056](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K222056.md) | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jan 26, 2023 | SESE | | [K220216](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K220216.md) | C-Stem AMT LE Prosthesis | Depuy Ireland UC | Jul 22, 2022 | SESE | | [K213701](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K213701.md) | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 1, 2022 | SESE | | [K213816](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K213816.md) | MPO Hip Instruments | Microport Orthopedics, Inc. | Jan 5, 2022 | SESE | | [K210842](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K210842.md) | VerSys Cemented Revision/Calcar | Zimmer, Inc. | Dec 10, 2021 | SESE | | [K203815](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K203815.md) | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | Jun 9, 2021 | SESE | | [K203588](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K203588.md) | ELEOS™ Limb Salvage System | Onkos Surgical | Feb 5, 2021 | SESE | | [K203090](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K203090.md) | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | Dec 11, 2020 | SESE | | [K201519](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K201519.md) | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | Dec 10, 2020 | SESE | | [K193429](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K193429.md) | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | Aug 13, 2020 | SESE | | [K191449](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K191449.md) | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | Jul 16, 2020 | SESE | | [K200823](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K200823.md) | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | Jul 9, 2020 | SESE | | [K191735](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K191735.md) | CPT Hip System | Zimmer, Inc. | Mar 20, 2020 | SESE | | [K191056](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K191056.md) | Conformity stem, cemented | United Orthopedic Corporation | Jan 3, 2020 | SESE | | [K191414](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K191414.md) | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | Aug 28, 2019 | SESE | ## Top Applicants - Biomet, Inc. — 50 clearances - Depuy, Inc. — 45 clearances - Howmedica Corp. — 35 clearances - Osteonics Corp. — 29 clearances - Zimmer, Inc. — 27 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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