Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3320](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3320) → JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) # JDL · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) _Orthopedic · 21 CFR 888.3320 · Class 3_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL ## Overview - **Product Code:** JDL - **Device Name:** Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) - **Regulation:** [21 CFR 888.3320](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3320) - **Device Class:** 3 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Classification Rationale Class III. ## Recent Cleared Devices (20 of 45) Showing 20 most recent of 45 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K073499](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K073499.md) | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | Zimmer, Inc. | Aug 7, 2008 | SESE | | [K070785](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K070785.md) | DYNASTY ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | Jul 11, 2007 | SESE | | [K061844](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K061844.md) | DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER | Wrightmedicaltechnologyinc | Dec 6, 2006 | SESE | | [K051995](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K051995.md) | PROFEMUR RENAISSANCE HIP STEM | Wrightmedicaltechnologyinc | Aug 22, 2005 | SESE | | [K051348](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K051348.md) | CONSERVE TOTAL FEMORAL HEAD | Wrightmedicaltechnologyinc | Aug 19, 2005 | SESE | | [K042841](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K042841.md) | M2A/C2A ACETABULAR SYSTEM | Biomet, Inc. | Dec 21, 2004 | SESE | | [K041586](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K041586.md) | PROFEMUR S HIP STEM | Wrightmedicaltechnologyinc | Jul 9, 2004 | SESE | | [K041114](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K041114.md) | PROFEMUR TAPERED HIP STEM | Wrightmedicaltechnologyinc | May 28, 2004 | SESE | | [K004043](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K004043.md) | METAL TRANSCEND ARTICULATION SYSTEM | Wrightmedicaltechnologyinc | Jul 13, 2001 | SESE | | [K950542](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K950542.md) | METAL BACKED ACETABULAR COMPONENT | Encore Orthopedics, Inc. | May 25, 1995 | SESE | | [K944769](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K944769.md) | P.F.C. APICAL PLUG | Johnson & Johnson Professionals, Inc. | Dec 8, 1994 | SESE | | [K942809](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K942809.md) | ACETABULAR DOME HOLE PLUGS | Osteonics Corp. | Sep 20, 1994 | SESE | | [K931676](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K931676.md) | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | Joint Medical Products Corp. | May 18, 1994 | SESE | | [K934440](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K934440.md) | PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES | Howmedica Corp. | Feb 22, 1994 | SESE | | [K930833](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K930833.md) | PCA(R) SOLID BACK ACETABULA SHELL | Howmedica Corp. | Feb 22, 1994 | SESE | | [K935669](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K935669.md) | SYRIGENE PRE-FILLED SYRINGE | Regulatory & Marketing Services, Inc. | Feb 18, 1994 | SESE | | [K922561](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K922561.md) | CONSENSUS(TM) TOTAL HIP SYSTEM | U.S. Medical Products, Inc. | Jul 21, 1993 | SESE | | [K915529](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K915529.md) | FPC/SFPC/RFPC ACETABULAR COMPONENT | Implantology Corp. | Jul 13, 1993 | SESE | | [K915527](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K915527.md) | CPS ACETABULAR COMPONENT | Implantology Corp. | Jun 24, 1993 | SESE | | [K922861](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K922861.md) | BIOMETRIC SCREW FIXATION CUP | Osteo Technology, Inc. | May 12, 1993 | SESE | ## Top Applicants - Wrightmedicaltechnologyinc — 7 clearances - Howmedica Corp. — 5 clearances - Kirschner Medical Corp. — 3 clearances - Osteonics Corp. — 3 clearances - Advanced Biosearch Assn. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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