Product code JDI
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3350
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | 2025-07-31 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | 2024-10-21 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 |
| K203588 | ELEOS™ Limb Salvage System | Onkos Surgical | 2021-02-05 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | 2020-12-10 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020-08-13 |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | 2020-07-16 |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020-07-09 |
| K191735 | CPT Hip System | Zimmer, Inc. | 2020-03-20 |
| K191056 | Conformity stem, cemented | United Orthopedic Corporation | 2020-01-03 |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | 2019-08-28 |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2019-02-11 |
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018-09-28 |
| K162125 | MALUC™ Total Hip Arthroplasty System | Surgtech, Inc. | 2017-05-10 |
| K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | 2016-11-17 |
| K153057 | FitRite™ Total Hip Arthroplasty System | Excera Orthopedics, Inc. | 2016-06-23 |
| K153725 | Corin TaperFit Hip Stem | Corin U.S.A. Limited | 2016-03-25 |
| K153216 | Alpine Cemented Hip System | Ortho Development Corporation | 2016-02-18 |
| K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015-10-14 |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015-06-25 |
| K142761 | Corin TaperFit Hip Stem | Corin USA | 2015-04-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07611996075038 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074901 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074918 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074925 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074956 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074963 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074970 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074987 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075007 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075021 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996081084 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996082500 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081091 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081107 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081114 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081121 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081138 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081497 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081503 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996013788 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081077 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081046 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081022 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081008 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996076394 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996065343 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996045208 | MODULAR-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996014990 | BOFOR/EP-FIT PLUS/PROMOS/MPF | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996013849 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996013795 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |