Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FDA product code JDI · Class II (moderate risk) · 21 CFR 888.3350 · Orthopedic
565510(k) clearances
0PMA approvals
235recalls
Implantimplanted device
Manufacturers
- Biomet, Inc. 51
- Depuy, Inc. 45
- Howmedica Corp. 43
- Osteonics Corp. 29
- Zimmer, Inc. 27
- Intermedics Orthopedics 21
- Howmedica Osteonics Corp. 17
- Kirschner Medical Corp. 17
- Orthomet, Inc. 16
- Encore Orthopedics, Inc. 13
- DePuy Orthopaedics, Inc. 12
- Exactech, Inc. 12
- Wrightmedicaltechnologyinc 11
- Implex Corp. 10
- Johnson & Johnson Professionals, Inc. 9
- Smith & Nephew, Inc. 8
- Joint Medical Products Corp. 8
- Richard'S Medical Equip., Inc. 7
- Richards Medical Co., Inc. 7
- Osteo Technology, Inc. 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | Biomet, Inc. | 07/01/2026SE |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 03/12/2026SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | Zimmer Biomet | 07/31/2025SE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
| K213701 | Exeter® X3® RimFit® CupJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/01/2022SE |
| K213816 | MPO Hip InstrumentsJDI · Special | Microport Orthopedics, Inc. | 01/05/2022SE |
| K210842 | VerSys Cemented Revision/CalcarJDI · Traditional | Zimmer, Inc. | 12/10/2021SE |
| K203815 | ELEOS Limb Salvage System with BioGripJDI · Traditional | Onkos Surgical | 06/09/2021SE |
| K203588 | ELEOS Limb Salvage SystemJDI · Traditional | Onkos Surgical | 02/05/2021SE |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIPJDI · Traditional | Onkos Surgical | 12/11/2020SE |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic StemJDI · Traditional | Microport Orthopedics, Inc. | 12/10/2020SE |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupJDI · Traditional | Howmedica Osteonics Corp. | 08/13/2020SE |
| K191449 | ZCA All-Poly Acetabular CupsJDI · Traditional | Zimmer, Inc. | 07/16/2020SE |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling IJDI · Traditional | Zimmer, Inc. | 07/09/2020SE |
| K191735 | CPT Hip SystemJDI · Traditional | Zimmer, Inc. | 03/20/2020SE |
| K191056 | Conformity stem, cementedJDI · Traditional | United Orthopedic Corporation | 01/03/2020SE |
| K191414 | EXETER Centralizer, EXETER 2.5mm PlugJDI · Traditional | Stryker Orthopaedics | 08/28/2019SE |
| K181340 | Cemented TSI Hip StemJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 02/11/2019SE |
| K180973 | Libertas Hip Replacement SystemJDI · Traditional | Maxx Orthopedics, Inc. | 09/28/2018SE |
| K162125 | MALUC Total Hip Arthroplasty SystemJDI · Traditional | Surgtech, Inc. | 05/10/2017SE |
| K160923 | REDAPT Anteverted Cemented LinerJDI · Traditional | Smith & Nephew, Inc. | 11/17/2016SE |
| K153057 | FitRite Total Hip Arthroplasty SystemJDI · Traditional | Excera Orthopedics, Inc. | 06/23/2016SE |
| K153725 | Corin TaperFit Hip StemJDI · Traditional | Corin U.S.A. Limited | 03/25/2016SE |
| K153216 | Alpine Cemented Hip SystemJDI · Traditional | Ortho Development Corporation | 02/18/2016SE |
| K152621 | OSS/Arcos IM Total Femur RodJDI · Special | Biomet, Inc. | 10/14/2015SE |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialJDI · Traditional | Biomet Manufacturing, LLC | 06/25/2015SE |
| K142761 | Corin TaperFit Hip StemJDI · Traditional | Corin USA | 04/03/2015SE |
| K141331 | Biomet Orthopaedic Salvage System (Oss)JDI · Traditional | Biomet, Inc. | 10/27/2014SE |
| K142295 | Sirius Femoral Stem, Size 30AJDI · Special | Biomet, Inc. | 09/15/2014SE |
| K141370 | Renovis Cemented Hip SystemJDI · Traditional | Renovis Surgical Technologies, Inc. | 09/02/2014SE |
| K130610 | Sirius Femoral StemJDI · Traditional | Biomet, Inc. | 08/30/2013SE |
| K123598 | Smith & Nephew, Inc. Hip System InstrumentationJDI · Traditional | Smith & Nephew, Inc. | 06/28/2013SE |
| K123501 | Oss Modular Stems, Oss Diaphyseal SegmentsJDI · Special | Biomet, Inc. | 02/27/2013SE |
| K121056 | Mets Modular Proximal FemurJDI · Traditional | Stanmore Implants Worldwide , Ltd. | 09/20/2012SE |
| K121055 | Mets Modular Total FemurJDI · Traditional | Stanmore Implants Worldwide , Ltd. | 09/19/2012SE |
| K111863 | Signature Planner,Signature GuidesJDI · Traditional | Materialise NV | 06/15/2012SE |
| K120578 | Accolade II Hip StemJDI · Special | Howmedica Osteonics | 03/29/2012SE |
| K111848 | Exeter X3 Rimfit Acetabular CupJDI · Traditional | Stryker Corp. | 10/05/2011SE |
| K110290 | Exeter Hip StemJDI · Traditional | Howmedica Osteonics Corp. | 09/27/2011SE |
| K093646 | Depuy Pinnacle with Gription Acetabular CupsJDI · Special | DePuy Orthopaedics, Inc. | 12/17/2009SE |
| K090998 | Depuy Pinnacle 100 with Gription Acetabular CupsJDI · Special | DePuy Orthopaedics, Inc. | 06/12/2009SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | Biopro, Inc. | 05/22/2009SE |
| K082792 | Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsJDI · Special | Medacta International S.A. | 12/29/2008SE |
| K082239 | Depuy C-Stem AmtJDI · Special | DePuy Orthopaedics, Inc. | 08/29/2008SE |
| K080539 | Accin Unipolar Head SystemJDI · Traditional | Accelerated Innovation, LLC | 06/02/2008SE |
| K080885 | Medacta Total Hip Prosthesis System - Line ExtensionJDI · Special | Medacta International S.A. | 04/28/2008SE |
| K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotJDI · Traditional | Medacta International S.A. | 02/04/2008SE |
| K070399 | 100KGY E-Poly Acetabular Liners-Additional ProfilesJDI · Special | Biomet Manufacturing, Inc. | 05/04/2007SE |
| K070364 | 100KGY E-Poly Maxrom Acetabular LinersJDI · Special | Biomet, Inc. | 05/03/2007SE |
| K063278 | Portland Cobalt Chrome Femoral HeadJDI · Traditional | Portland Orthopaedics Limited | 01/12/2007SE |
| K061344 | Excia Total Hip System Lateral OffsetJDI · Special | Aesculap, Inc. | 08/02/2006SE |
| K052639 | Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerJDI · Traditional | Biomet Manufacturing, Inc. | 05/03/2006SE |
| K052748 | System 12 X3 Acetabular Inserts; Series II X3 Acetabular InsertsJDI · Traditional | Howmedica Osteonics Corp. | 12/02/2005SE |
| K052792 | Anthology Hip StemJDI · Special | Smith & Nephew, Inc. | 10/07/2005SE |
| K051569 | Ringloc Bi-Polar Acetabular ComponentJDI · Traditional | Biomet, Inc. | 09/29/2005SE |
| K050637 | Encompass Cemented Hip Stem & 10/12 Cobalt-Chrome Femoral HeadsJDI · Traditional | Ortho Development Corp. | 09/23/2005SE |
| K051407 | Legend All-Poly CupJDI · Traditional | Ortho Development Corp. | 09/08/2005SE |
| K051516 | Trabecular Metal Revision Shell LinersJDI · Special | Zimmer, Inc. | 07/27/2005SE |
| K050441 | Taper 2 Porous Femoral StemJDI · Traditional | Biomet, Inc. | 06/29/2005SE |
| K051363 | Restoration Modular SystemJDI · Special | Howmedica Osteonics Corp. | 06/23/2005SE |
| K051335 | Acumatch 12/14 Press-Fit Femoral StemsJDI · Special | Exactech, Inc. | 06/21/2005SE |
| K050105 | Nexgen Complete Knee Solution Distal Femoral SpacersJDI · Traditional | Zimmer, Inc. | 05/17/2005SE |
| K050138 | Modification to: Restoration Modular SystemJDI · Special | Howmedica Osteonics Corp. | 03/21/2005SE |
| K042959 | Depuy C-Stem Amt Hip ProsthesisJDI · Special | DePuy Orthopaedics, Inc. | 12/22/2004SE |
| K033871 | Im Total FemurJDI · Traditional | Biomet, Inc. | 04/16/2004SE |
| K032730 | Fixion Hip SystemJDI · Traditional | Disc-O-Tech Medical Technologies, Ltd. | 03/26/2004SE |
| K034028 | Ath Femoral StemJDI · Special | Wrightmedicaltechnologyinc | 03/11/2004SE |
| K031474 | SC Total Hip SystemJDI · Traditional | Orthopedic Alliance, LLC | 10/15/2003SE |
| K030867 | Eska Modular Hip System CementedJDI · Traditional | Eska Implants GmbH | 09/22/2003SE |
| K031730 | 36MM Orthinox V40 Femoral Head ComponentsJDI · Special | Howmedica Osteonics Corp. | 08/29/2003SE |
| K032396 | Ringloc 36MM Line and Modular Femoral HeadsJDI · Special | Biomet, Inc. | 08/21/2003SE |
| K031744 | Omnifit HFX Hip Stem SeriesJDI · Traditional | Howmedica Osteonics Corp. | 08/08/2003SE |
| K030766 | Oxinium Femoral HeadsJDI · Special | Smith & Nephew, Inc. | 07/25/2003SE |
| K031734 | Generation 4 Polished Femoral Hip ProsthesisJDI · Special | Biomet, Inc. | 07/01/2003SE |
| K031165 | Plus Orthopedics Cemented Hip StemJDI · Traditional | Plus Orthopedics | 06/06/2003SE |
| K030153 | Zca All-Poly Acetabular Cup, Snap-In, Model 8005-946/958-32JDI · Traditional | Zimmer, Inc. | 04/01/2003SE |
| K030265 | CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00JDI · Special | Zimmer, Inc. | 03/04/2003SE |
| K024340 | Smith & Nephew Femoral HeadsJDI · Special | Smith & Nephew, Inc. | 02/26/2003SE |
| K022799 | Trident Screw Hole Plug and Trident Bone SpikeJDI · Traditional | Howmedica Osteonics Corp. | 11/21/2002SE |
| K023646 | Exatech Acumatch Integrated Hip System C-Series Cemented Femoral StemJDI · Special | Exactech, Inc. | 11/13/2002SE |
| K023453 | Depuy Summit FX Cemented Hip ProsthesisJDI · Special | DePuy Orthopaedics, Inc. | 11/13/2002SE |
| K023085 | RX 90 Femoral Stem and RX 90 Lateralized Femoral StemJDI · Special | Biomet Orthopedics, Inc. | 10/17/2002SE |
| K022958 | Total Hip Femoral Heads and LinersJDI · Special | Smith & Nephew, Inc. | 10/02/2002SE |
| K022094 | Par 5 Acetabular Component with & Without Hydroxyapatite CoatingJDI · Special | Biomet, Inc. | 07/25/2002SE |
| K022077 | 36MM V40 Femoral Head Components (Lfit and Non-Lfit)JDI · Special | Howmedica Osteonics Corp. | 07/25/2002SE |
| K021822 | R120 Modular Total Hip SystemJDI · Traditional | Osteoimplant Technology, Inc. | 07/23/2002SE |
| K021380 | Oss Les Proximal Femoral ComponentJDI · Special | Biomet, Inc. | 05/28/2002SE |
| K021310 | 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)JDI · Special | Howmedica Osteonics Corp. | 05/21/2002SE |
| K021178 | Sl-Plus Lateralized StemJDI · Special | Plus Orthopedics | 05/14/2002SE |
| K020989 | Super Eon Plus Femoral StemsJDI · Special | Howmedica Osteonics Corp. | 04/26/2002SE |
| K020970 | Modification to Oncology Salvage System (Oss)JDI · Special | Biomet, Inc. | 04/04/2002SE |
| K020291 | Exactech, Model Pmma Femoral Stem CentralizerJDI · Special | Exactech, Inc. | 02/27/2002SE |
| K020076 | Patriot Protrusio CageJDI · Special | Biomet Orthopedics, Inc. | 01/30/2002SE |
| K011887 | Avalon Cup SystemJDI · Traditional | Orthopedic Source, Inc. | 12/27/2001SE |
| K013352 | Summit Cemented Hip ProsthesisJDI · Traditional | DePuy Orthopaedics, Inc. | 12/17/2001SE |
| K013350 | Modification to Depuy C-Stem SystemJDI · Special | DePuy Orthopaedics, Inc. | 11/07/2001SE |
| K012961 | Sulzer Orthopedics Converge Acetabular SystemJDI · Special | Sulzer Orthopedics, Inc. | 10/18/2001SE |
| K011774 | R120 Modular Total Hip SystemJDI · Traditional | Osteoimplant Technology, Inc. | 09/05/2001SE |
| K012493 | Acumatch C-Series Cemented Femoral Component, Model Size 0JDI · Special | Exactech, Inc. | 08/29/2001SE |
| K011715 | Macropore Ib Resorbable PlugJDI · Traditional | Macropore Biosurgery, Inc. | 08/27/2001SESU |
| K012019 | Color Buffed (CB) DDH Femoral StemJDI · Special | Biomet, Inc. | 07/20/2001SE |
| K012026 | Trident All Poly CupJDI · Special | Howmedica Osteonics Corp. | 07/18/2001SE |
| K011455 | Biomet Oncology Salvage System (Oss) Taper Stacking AdapterJDI · Traditional | Biomet, Inc. | 07/18/2001SE |
| K011623 | Exeter Hip System with V40 TaperJDI · Special | Howmedica Osteonics Corp. | 06/15/2001SE |
| K011367 | Excel Fracture Cemented Hip StemJDI · Traditional | DePuy Orthopaedics, Inc. | 06/15/2001SE |
| K011218 | Acumatch L-Series Cemented Femoral Stem, Model Size 1JDI · Special | Exactech, Inc. | 05/16/2001SE |
| K010529 | Titanium Cement Restrictor Material PldlaJDI · Special | Medtronic Sofamor Danek USA, Inc. | 04/27/2001SESU |
| K010757 | Lfit V40 Femoral Head ComponentsJDI · Special | Howmedica Osteonics Corp. | 04/11/2001SE |
| K010310 | Modification to Trident All Poly CupJDI · Special | Howmedica Osteonics Corp. | 03/20/2001SE |
| K003976 | Baumer Muller Hip ProsthesisJDI · Traditional | Baumer, S.A | 03/19/2001SE |
| K003975 | Baumer Cemented Hip ProsthesisJDI · Traditional | Baumer, S.A | 03/19/2001SE |
| K003666 | Taper-Fit Total Hip SystemJDI · Traditional | Corin USA | 02/08/2001SE |
| K001956 | Trident All Poly CupJDI · Traditional | Howmedica Osteonics Corp. | 12/11/2000SE |
| K003421 | Depuy C-Stem SystemJDI · Special | DePuy Orthopaedics, Inc. | 12/01/2000SE |
| K002757 | Oncology Salvage SystemJDI · Traditional | Biomet, Inc. | 11/24/2000SE |
| K002324 | Modified to Modular FR Severe Bone Loss TraumaJDI · Special | Sulzermedica | 08/24/2000SE |
| K001759 | Hedrocel Revision Cup, Model 02-2YY-ZZZZJDI · Traditional | Implex Corp. | 08/24/2000SE |
| K001571 | Baumer Femoral HeadJDI · Traditional | Baumer, S.A | 08/04/2000SE |
| K002106 | New Bio-Moore Endo Head, Taper AdapterJDI · Special | Biomet, Inc. | 07/27/2000SE |
| K001932 | Tornier Cement RestrictorJDI · Special | Tornier | 07/20/2000SE |
| K001376 | Ti-Max Protrusio CageJDI · Traditional | Biomet, Inc. | 07/20/2000SE |
| K001078 | Sulzer Orthopedics MS-30 Femoral StemJDI · Traditional | Sulzer Orthopedics, Inc. | 06/23/2000SE |
| K001733 | Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…JDI · Traditional | Zimmer, Inc. | 06/20/2000SE |
| K000817 | Omega II Modular Total Hip SystemJDI · Traditional | Osteoimplant Technology, Inc. | 06/08/2000SE |
| K001335 | Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedJDI · Special | Exactech, Inc. | 05/18/2000SE |
| K990330 | Cross Linked Polyethylene Acetabular Components,Model Xx-Yy-ZzzzzzJDI · Traditional | Implex Corp. | 03/01/2000SE |
| K000254 | Par 5 Acetabular ComponentJDI · Special | Biomet, Inc. | 02/07/2000SE |
| K994007 | Mallory/Head Smooth Femoral ComponentJDI · Traditional | Biomet, Inc. | 02/04/2000SE |
| K993713 | Rim-Fix, Acetabular CupJDI · Traditional | Surgical Implants, Inc. | 01/28/2000SE |
| K992409 | The Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZJDI · Traditional | Implex Corp. | 10/08/1999SE |
| K992153 | Pe-Plus Acetabular CupJDI · Traditional | Plus Orthopedics | 09/23/1999SE |
| K992903 | Color Buffed Cemented FemoralJDI · Special | Biomet, Inc. | 09/17/1999SE |
| K992490 | B2C Hip SystemJDI · Traditional | Lepine Groupe Spa. | 08/19/1999SE |
| K991869 | Cobrex Hip Stem, Model 01-128-XXXXXJDI · Abbreviated | Implex Corp. | 07/14/1999SE |
| K991622 | 26 MM Cast Cocr Head and Polyethylene Acetabular Shell LinerJDI · Traditional | Stelkast Company | 07/14/1999SE |
| K992058 | Bi-Metric Ccocr Head/Neck Replacement SystemJDI · Special | Biomet, Inc. | 07/01/1999SE |
| K991987 | Color Buffed Answer Cemented FemoralJDI · Special | Biomet, Inc. | 06/28/1999SE |
| K991538 | Opera Cupflanged Acetabular ComponentsJDI · Abbreviated | Smith & Nephew, Inc., Orthopaedic Div. | 06/03/1999SE |
| K991227 | 8MM Forged Cemented StemJDI · Traditional | Encore Orthopedics, Inc. | 06/01/1999SE |
| K990821 | Providence Cup SystemJDI · Traditional | Biopro, Inc. | 04/29/1999SE |
| K984227 | Omega II Modular Total Hip SystemJDI · Traditional | Osteoimplant Technology, Inc. | 04/08/1999SE |
| K990369 | Synergy Cemented Hip StemJDI · Abbreviated | Smith & Nephew, Inc. | 03/12/1999SE |
| K990032 | Modular Protusio CupJDI · Traditional | Biomet, Inc. | 02/18/1999SE |
| K984154 | Apf Porous Coated Line ExtensionJDI · Traditional | Biomet, Inc. | 02/11/1999SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | Howmedica Corp. | 12/16/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | Howmedica Corp. | 12/11/1998SE |
| K983226 | Osteonics X Cemented Hip Stem SeriesJDI · Traditional | Osteonics Corp. | 12/04/1998SE |
| K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-XXYYY, 02-247-XXYYY…JDI · Traditional | Implex Corp. | 12/03/1998SE |
| K983710 | 150MM Cocr Bimetric Head/Neck Replacement Hip Stem- Color Buff FinishJDI · Traditional | Biomet, Inc. | 12/02/1998SE |
| K983136 | Depuy Luster StemJDI · Traditional | DePuy Orthopaedics, Inc. | 11/25/1998SE |
| K982963 | Polymer Threaded Anchor / Suture CombinationJDI · Traditional | Orthopaedic Biosystems, Ltd. | 11/20/1998SE |
| K982918 | Depuy C-Stem SystemJDI · Traditional | DePuy Orthopaedics, Inc. | 10/05/1998SE |
| K982670 | Contemporary Acetabular ComponentJDI · Traditional | Howmedica Corp. | 10/02/1998SE |
| K982598 | Oti Femoral Lock Total Hip SystemJDI · Traditional | Osteoimplant Technology, Inc. | 10/02/1998SE |
| K974685 | Osteonics Polyethylene Acetabular ComponentsJDI · Traditional | Osteonics Corp. | 09/22/1998SE |
| K981855 | Prince Medical Cement PlugJDI · Traditional | Prince Medical, Inc. | 08/10/1998SE |
| K980813 | Reliance Long Stem Femoral ComponentsJDI · Traditional | Howmedica, Inc. | 06/26/1998SE |
| K980843 | Exeter Intramedullary Bone PlugJDI · Traditional | Howmedica, Inc. | 06/02/1998SE |
| K980794 | Dual Lock Hip StemJDI · Traditional | Depuy, Inc. | 05/20/1998SE |
| K980513 | Articul/Eze Femoral HeadsJDI · Traditional | DePuy Orthopaedics, Inc. | 04/14/1998SE |
| K980486 | Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 SystemJDI · Traditional | Implex Corp. | 04/14/1998SE |
| K980286 | Ultima Acetabular Roof Reinforcement RingJDI · Traditional | Johnson & Johnson Professionals, Inc. | 04/03/1998SE |
| K974558 | Salvage/Onocology Hip and Total Femur SystemJDI · Traditional | Biomet, Inc. | 03/04/1998SE |
| K972791 | Encore Linear HipJDI · Traditional | Encore Orthopedics, Inc. | 01/12/1998SN |
| K973809 | Foundation Fracture StemJDI · Traditional | Encore Orthopedics, Inc. | 01/02/1998SE |
| K974054 | Distal Centralizer, Exeter II Hip SystemJDI · Traditional | Howmedica, Inc. | 12/23/1997SE |
| K973453 | Tornier Cement RestrictorJDI · Traditional | Tornier | 12/09/1997SE |
| K971681 | SMC Femoral Hip ComponentJDI · Traditional | Signal Medical Corp. | 12/04/1997SE |
| K973296 | Extend Hip StemJDI · Traditional | Wrightmedicaltechnologyinc | 11/24/1997SE |
| K972995 | The C-Fit & Dc-Fit Acetabular Cup SystemJDI · Traditional | Corin USA | 11/10/1997SE |
| K972961 | Stelkast Bipolar SystemJDI · Traditional | Stelkast Company | 11/04/1997SE |
| K972928 | Kerboull CrossJDI · Traditional | Howmedica, Inc. | 11/03/1997SN |
| K972792 | Duration Stabilized Uhmwpe Acetabular ComponentsJDI · Traditional | Howmedica Corp. | 10/16/1997SE |
| K972641 | Dual Offset Perfecta Imc Hip StemJDI · Traditional | Wrightmedicaltechnologyinc | 10/09/1997SE |
| K972460 | Osteonics Omnifit-C Cemented Hip Stem (Line Extension)JDI · Traditional | Osteonics Corp. | 09/25/1997SE |
| K972435 | Ultima and Ultima LX Cemented Femoral StemJDI · Traditional | Johnson & Johnson Professionals, Inc. | 09/11/1997SE |
| K971890 | Recovery Protrusio CageJDI · Traditional | Biomet, Inc. | 08/07/1997SE |
| K971705 | Implex Hep Acetabular Cup System, CementedJDI · Traditional | Implex Corp. | 08/06/1997SE |
| K971581 | Hemisphere Cemented CupJDI · Traditional | Ortho Development Corp. | 07/18/1997SE |
| K963612 | Duration Stabilized UhmwpeJDI · Traditional | Howmedica Corp. | 06/11/1997SE |
| K970697 | Osteonics Normalized Ad Acetabular Component SystemJDI · Traditional | Osteonics Corp. | 04/24/1997SE |
| K970194 | Proform Cemented Titanium Revision Femoral ComponentJDI · Traditional | Stelkast Company | 04/14/1997SE |
| K965019 | The C-Fit Femoral Hip SystemJDI · Traditional | Corin USA | 03/25/1997SE |
| K964003 | Metagen All Poly Acetabular Cup SystemJDI · Traditional | Metagen, LLC | 03/21/1997SE |
| K970351 | Global Taper Spectron Hip StemsJDI · Traditional | Smith & Nephew, Inc., Orthopaedic Div. | 02/28/1997SE |
| K964795 | Cemented Calcar Replacement Femoral StemJDI · Traditional | Johnson & Johnson Professionals, Inc. | 02/19/1997SE |
| K964655 | Uhmwpe Hip and Knee Components - Packaging ChangeJDI · Traditional | Howmedica Corp. | 02/06/1997SE |
| K963671 | Osteonics Flanged Polyethylene Acetabular CupJDI · Traditional | Osteonics Corp. | 02/03/1997SE |
| K962468 | Hedrocel Acetabular RestrictorJDI · Traditional | Implex Corp. | 02/03/1997SE |
| K964350 | Modula Options for Severe Bone Loss and TraumaJDI · Traditional | Intermedics Orthopedics | 01/16/1997SE |
| K963109 | Heritage Hip SystemJDI · Traditional | Zimmer, Inc. | 01/09/1997SE |
| K964218 | Perfecta Plasma Spray Hip StemJDI · Traditional | Wrightmedicaltechnologyinc | 01/08/1997SE |
| K964262 | Exactech Total Hip Systme: 22MM Femoral HeadJDI · Traditional | Exactech, Inc. | 12/27/1996SE |
| K963486 | Revision Hip SystemJDI · Traditional | Smith & Nephew Richards, Inc. | 11/27/1996SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0153-2026 Class II | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD…Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility… | BioPro, Inc. | 09/09/2025Open, Classified |
| Z-2640-2025 Class II | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM…a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain… | Howmedica Osteonics Corp. | 08/28/2025Open, Classified |
| Z-2425-2025 Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED.…Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | Onkos Surgical, Inc. | 07/11/2025Open, Classified |
| Z-2424-2025 Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED…Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | Onkos Surgical, Inc. | 07/11/2025Open, Classified |
| Z-2423-2025 Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem…Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | Onkos Surgical, Inc. | 07/11/2025Open, Classified |
| Z-2732-2024 Class II | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient…A patient specific, custom-made device was supplied for a surgical procedure that did not match the design… | Howmedica Osteonics Corp. | 08/05/2024Open, Classified |
| Z-2450-2024 Class II | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip…Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is… | Zimmer, Inc. | 07/02/2024Open, Classified |
| Z-2179-2024 Class II | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip…41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint… | Biomet, Inc. | 05/17/2024Open, Classified |
| Z-1818-2025 Class II | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component…Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in… | Onkos Surgical, Inc. | 12/22/2023Open, Classified |
| Z-1817-2025 Class II | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component…Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in… | Onkos Surgical, Inc. | 12/22/2023Open, Classified |
| Z-1883-2025 Class II | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M…Potential for breach of Tyvek seals. | Onkos Surgical, Inc. | 09/01/2023Open, Classified |
| Z-2519-2023 Class II | M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number…The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice… | Zimmer, Inc. | 07/26/2023Open, Classified |
| Z-1734-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | Exactech, Inc. | 08/11/2022Open, Classified |
| Z-1733-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | Exactech, Inc. | 08/11/2022Open, Classified |
| Z-1509-2022 Class II | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS…One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3… | Corin Ltd | 07/22/2022Open, Classified |
| Z-1667-2022 Class II | TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use…Some of the devices did not pass fatigue testing. | Corin Ltd | 07/12/2022Terminated |
| Z-1225-2022 Class II | PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECKOne manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. | MicroPort Orthopedics Inc. | 05/04/2022Terminated |
| Z-1845-2021 Class II | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained…Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size… | DePuy Orthopaedics, Inc. | 05/07/2021Terminated |
| Z-0623-2021 Class II | OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | Biomet, Inc. | 11/25/2020Terminated |
| Z-0397-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0396-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0395-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0394-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0393-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0392-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0391-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0390-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0389-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0388-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0387-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0386-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0385-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0384-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0383-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0382-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0381-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0380-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0379-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0378-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0377-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0376-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0375-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0374-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0373-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0372-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0371-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0370-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0369-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0368-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |
| Z-0367-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | Zimmer Biomet, Inc. | 09/24/2020Terminated |