ClearanceBrief
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

ApplicantWrightmedicaltechnologyinc, Arlington TN, US
DecisionSubstantially Equivalent, Mar 6, 2009
ReceivedOct 1, 2008
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K082924

DateFirm and productCodeLinked 510(k)
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Feb 14, 2012Wright 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
KWANone listed
Aug 12, 2010Wright 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
JDLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.