ClearanceBrief
510(k) K953510 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS

ApplicantEncore Orthopedics, Inc., Austin TX, US
DecisionSubstantially Equivalent, Aug 9, 1995
ReceivedJul 26, 1995
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K953510

DateFirm and productCodeLinked 510(k)
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed
Nov 7, 2007Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Terminated
KWYNone listed

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