510(k) K082924 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Mar 6, 2009 |
| Received | Oct 1, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Feb 14, 2012 | Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.
The instrument is used as a hip acetabular sh Terminated |
KWA | None listed |
| Aug 12, 2010 | Wright Medical Technology Inc DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in Terminated |
JDL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.