Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
FDA product code JDL · Class III (high risk) · 21 CFR 888.3320 · Orthopedic
45510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Wrightmedicaltechnologyinc 7
- Howmedica Corp. 5
- Osteonics Corp. 3
- Kirschner Medical Corp. 3
- Intermedics Orthopedics 2
- Implantology Corp. 2
- Biomet, Inc. 2
- Dow Corning Wright 2
- Link America, Inc. 2
- Advanced Biosearch Assn. 2
- Devcom, Inc. 1
- Orthopaedic Device Corp. 1
- Arrow Intl., Inc. 1
- Exactech, Inc. 1
- Synergy Orthopaedics Intl., Inc. 1
- Carbomedics, Inc. 1
- Techmedica, Inc. 1
- Osteo Technology, Inc. 1
- Endomedics, Inc. 1
- U.S. Medical Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional | Zimmer, Inc. | 08/07/2008SE |
| K070785 | Dynasty Acetabular SystemJDL · Special | Wrightmedicaltechnologyinc | 07/11/2007SE |
| K061844 | Dynasty Acetabular Shell and Cocr Acetabular LinerJDL · Special | Wrightmedicaltechnologyinc | 12/06/2006SE |
| K051995 | Profemur Renaissance Hip StemJDL · Special | Wrightmedicaltechnologyinc | 08/22/2005SE |
| K051348 | Conserve Total Femoral HeadJDL · Traditional | Wrightmedicaltechnologyinc | 08/19/2005SE |
| K042841 | M2A/C2A Acetabular SystemJDL · Traditional | Biomet, Inc. | 12/21/2004SE |
| K041586 | Profemur S Hip StemJDL · Special | Wrightmedicaltechnologyinc | 07/09/2004SE |
| K041114 | Profemur Tapered Hip StemJDL · Special | Wrightmedicaltechnologyinc | 05/28/2004SE |
| K004043 | Metal Transcend Articulation SystemJDL · Abbreviated | Wrightmedicaltechnologyinc | 07/13/2001SE |
| K950542 | Metal Backed Acetabular ComponentJDL · Traditional | Encore Orthopedics, Inc. | 05/25/1995SE |
| K944769 | P.F.C. Apical PlugJDL · Traditional | Johnson & Johnson Professionals, Inc. | 12/08/1994SE |
| K942809 | Acetabular Dome Hole PlugsJDL · Traditional | Osteonics Corp. | 09/20/1994SE |
| K931676 | S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole PlugJDL · Traditional | Joint Medical Products Corp. | 05/18/1994SE |
| K934440 | Pca Acetabular Insert II, Additional Sizes, StylesJDL · Traditional | Howmedica Corp. | 02/22/1994SE |
| K930833 | Pca(R) Solid Back Acetabula ShellJDL · Traditional | Howmedica Corp. | 02/22/1994SE |
| K935669 | Syrigene Pre-Filled SyringeJDL · Traditional | Regulatory & Marketing Services, Inc. | 02/18/1994SE |
| K922561 | Consensus(Tm) Total Hip SystemJDL · Traditional | U.S. Medical Products, Inc. | 07/21/1993SE |
| K915529 | Fpc/Sfpc/Rfpc Acetabular ComponentJDL · Traditional | Implantology Corp. | 07/13/1993SE |
| K915527 | CPS Acetabular ComponentJDL · Traditional | Implantology Corp. | 06/24/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | Osteo Technology, Inc. | 05/12/1993SE |
| K920929 | Poly Insert 20 DegreeJDL · Traditional | Dow Corning Wright | 05/05/1993SE |
| K925181 | Techmedica Mueller Type Polyethylene Acetbul CupJDL · Traditional | Techmedica, Inc. | 02/05/1993SE |
| K921139 | Healey Revision Component SystemJDL · Traditional | Biomet, Inc. | 07/01/1992SE |
| K921384 | Pca Acetabular Insert IIJDL · Traditional | Howmedica Corp. | 06/25/1992SE |
| K920868 | Acetabular Dome and Screw Hole PlugsJDL · Traditional | Osteonics Corp. | 05/26/1992SE |
| K896614 | S.A.F. Acetabular Cup with Porous CoatingJDL · Traditional | Synergy Orthopaedics Intl., Inc. | 01/09/1990SN |
| K895607 | Porous Coated Total Hip Pros. Acetabular ComponentJDL · Traditional | Exactech, Inc. | 11/17/1989SN |
| K894965 | Porous-Coated Titanium Acetabular CupJDL · Traditional | Dow Corning Wright | 11/17/1989SN |
| K892640 | Pneumothorax Kit, MotificationJDL · Traditional | Arrow Intl., Inc. | 10/11/1989SE |
| K870867 | KM-4(TM) Metal-Backed Acetabular CupJDL · Traditional | Kirschner Medical Corp. | 05/08/1987SE |
| K870234 | P.T.H. Metal-Backed Acetabular CupJDL · Traditional | Orthopaedic Device Corp. | 03/20/1987SE |
| K861264 | Joint Measurement IndicatorJDL · Traditional | Devcom, Inc. | 04/15/1986SE |
| K855042 | KM-3 Acetabular ComponentJDL · Traditional | Kirschner Medical Corp. | 03/14/1986SN |
| K854107 | Dimension Total Hip Prosthesis Porous CoatedJDL · Traditional | Kirschner Medical Corp. | 03/10/1986SN |
| K854935 | Link Metal-Backed Acetabular CupsJDL · Traditional | Link America, Inc. | 03/05/1986SE |
| K852369 | Lidgrer-Lund Acetabular SocketsJDL · Traditional | Link America, Inc. | 06/18/1985SE |
| K850793 | Modified Anatomic Porous Replacement Apr AcetabulaJDL · Traditional | Intermedics Orthopedics | 05/09/1985SE |
| K850352 | Micro-Struc. Acetabular Compon- MC2PJDL · Traditional | Osteonics Corp. | 04/25/1985SE |
| K844482 | Muller Titanium Backed Acetabular Cup ComponentJDL · Traditional | Advanced Biosearch Assn. | 02/19/1985SE |
| K842893 | Dorr Hip Prosthesis, Acetabular ComponJDL · Traditional | Carbomedics, Inc. | 11/08/1984SE |
| K831792 | Self-Aligning Acetabular ComponentJDL · Traditional | Endomedics, Inc. | 09/20/1984SE |
| K830662 | Natural Lock Acetabular ComponentJDL · Traditional | Advanced Biosearch Assn. | 04/11/1983SE |
| K813599 | 101-32 Femoral ComponentJDL · Traditional | Intermedics Orthopedics | 01/22/1982SE |
| K790274 | BG Proximal FemurJDL · Traditional | Howmedica Corp. | 03/26/1979SE |
| K770472 | Prosthesis, Vidal Total HipJDL · Traditional | Howmedica Corp. | 03/17/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3196-2026 | OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-2212-2010 | DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36…The inner and outer product packaging was missing the following information: shelf life, translations… | Wright Medical Technology Inc | 06/07/2010Terminated |
| Z-1716-2009 | CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length:…Incorrect packaging, swapped sizes | Wright Medical Technology Inc | 05/14/2009Terminated |
| Z-1715-2009 | CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length:…Incorrect packaging, swapped sizes | Wright Medical Technology Inc | 05/14/2009Terminated |