Panels › Orthopedic › Product code JDI · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation 888.3350
3510(k)s in 12 months (565 all time)
0recalls in 12 months (255 all time)
161recalls that name a 510(k)
Top companies in JDI
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet | 1 | 92 |
| Biomet, Inc. | 51 | 18 |
| Zimmer, Inc. | 27 | 23 |
| Depuy, Inc. | 45 | 0 |
| Howmedica Corp. | 43 | 0 |
| Stryker Howmedica Osteonics | 0 | 37 |
| DePuy Orthopaedics, Inc. | 12 | 20 |
| Osteonics Corp. | 29 | 0 |
| Howmedica Osteonics | 17 | 11 |
| Intermedics Orthopedics | 21 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2026 | K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments Biomet Orthopedics, Inc. | JDI |
| Jul 1, 2026 | K253434 | OSSTM Orthopedic Salvage System Biomet, Inc. | JDI |
| Mar 12, 2026 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head Signature Orthopaedics Pty, Ltd., AU | JDI |
| Jul 31, 2025 | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners Zimmer Biomet | JDI |
| Oct 21, 2024 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems Smith & Nephew, Inc. | JDI |
| Aug 2, 2024 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Apr 12, 2024 | K240418 | Stryker Orthopaedics Hip Systems Labeling Update Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Dec 8, 2023 | K233261 | Global Modular Replacement System Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | JDI |
| Jan 26, 2023 | K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Jul 22, 2022 | K220216 | C-Stem AMT LE Prosthesis Depuy Ireland UC, IE | JDI |
| Feb 1, 2022 | K213701 | Exeter® X3® RimFit® Cup Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Jan 5, 2022 | K213816 | MPO Hip Instruments Microport Orthopedics, Inc. | JDI |
| Dec 10, 2021 | K210842 | VerSys Cemented Revision/Calcar Zimmer, Inc. | JDI |
| Jun 9, 2021 | K203815 | ELEOS Limb Salvage System with BioGrip Onkos Surgical | JDI |
| Feb 5, 2021 | K203588 | ELEOS Limb Salvage System Onkos Surgical | JDI |
| Dec 11, 2020 | K203090 | ELEOS Limb Salvage System featuring BIOGRIP Onkos Surgical | JDI |
| Dec 10, 2020 | K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem Microport Orthopedics, Inc. | JDI |
| Aug 13, 2020 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Howmedica Osteonics Corp. | JDI |
| Jul 16, 2020 | K191449 | ZCA All-Poly Acetabular Cups Zimmer, Inc. | JDI |
| Jul 9, 2020 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer, Inc. | JDI |
| Mar 20, 2020 | K191735 | CPT Hip System Zimmer, Inc. | JDI |
| Jan 3, 2020 | K191056 | Conformity stem, cemented United Orthopedic Corporation, TW | JDI |
| Aug 28, 2019 | K191414 | EXETER Centralizer, EXETER 2.5mm Plug Stryker Orthopaedics | JDI |
| Feb 11, 2019 | K181340 | Cemented TSI Hip Stem Signature Orthopaedics Pty, Ltd., AU | JDI |
| Sep 28, 2018 | K180973 | Libertas Hip Replacement System Maxx Orthopedics, Inc. | JDI |
| May 10, 2017 | K162125 | MALUC Total Hip Arthroplasty System Surgtech, Inc. | JDI |
| Nov 17, 2016 | K160923 | REDAPT Anteverted Cemented Liner Smith & Nephew, Inc. | JDI |
| Jun 23, 2016 | K153057 | FitRite Total Hip Arthroplasty System Excera Orthopedics, Inc. | JDI |
| Mar 25, 2016 | K153725 | Corin TaperFit Hip Stem Corin U.S.A. Limited | JDI |
| Feb 18, 2016 | K153216 | Alpine Cemented Hip System Ortho Development Corporation | JDI |
| Oct 14, 2015 | K152621 | OSS/Arcos IM Total Femur Rod Biomet, Inc. | JDI |
| Jun 25, 2015 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial Biomet Manufacturing, LLC | JDI |
| Apr 3, 2015 | K142761 | Corin TaperFit Hip Stem Corin USA | JDI |
| Oct 27, 2014 | K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) Biomet, Inc. | JDI |
| Sep 15, 2014 | K142295 | Sirius Femoral Stem, Size 30A Biomet, Inc. | JDI |
| Sep 2, 2014 | K141370 | RENOVIS CEMENTED HIP SYSTEM Renovis Surgical Technologies, Inc. | JDI |
| Aug 30, 2013 | K130610 | SIRIUS FEMORAL STEM Biomet, Inc. | JDI |
| Jun 28, 2013 | K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION Smith & Nephew, Inc. | JDI |
| Feb 27, 2013 | K123501 | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS Biomet, Inc. | JDI |
| Sep 20, 2012 | K121056 | METS MODULAR PROXIMAL FEMUR Stanmore Implants Worldwide , Ltd. | JDI |
| Sep 19, 2012 | K121055 | METS MODULAR TOTAL FEMUR Stanmore Implants Worldwide , Ltd. | JDI |
| Jun 15, 2012 | K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES Materialise NV, BE | JDI |
| Mar 29, 2012 | K120578 | ACCOLADE II HIP STEM Howmedica Osteonics | JDI |
| Oct 5, 2011 | K111848 | EXETER X3 RIMFIT ACETABULAR CUP Stryker Corp. | JDI |
| Sep 27, 2011 | K110290 | EXETER HIP STEM Howmedica Osteonics Corp. | JDI |
| Dec 17, 2009 | K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DePuy Orthopaedics, Inc. | JDI |
| Jun 12, 2009 | K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS DePuy Orthopaedics, Inc. | JDI |
| May 22, 2009 | K090208 | BIOPRO FEMORAL HEADS Biopro, Inc. | JDI |
| Dec 29, 2008 | K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS Medacta International S.A. | JDI |
| Aug 29, 2008 | K082239 | DEPUY C-STEM AMT DePuy Orthopaedics, Inc. | JDI |
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