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 |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026-08-24 |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327380392 | TRIDENT II | Howmedica Osteonics Corp. | 2018-02-12 |
| 07613327345117 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345100 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345094 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345070 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345063 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345049 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345032 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345025 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345018 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327345001 | Trident II | Howmedica Osteonics Corp. | 2016-10-20 |
| 07613327039542 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273291 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273260 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327039771 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012804 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012972 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012965 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012958 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012941 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012903 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012897 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012880 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012873 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012866 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012859 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012842 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012835 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012828 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012811 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |