ClearanceBrief
510(k) K800207 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal

UHR UNIVERSAL6HIP REPLACEMENT

ApplicantOsteonics Corp., Mchenry IL, US
DecisionSubstantially Equivalent, Feb 11, 1980
ReceivedJan 30, 1980
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K800207

DateFirm and productCodeLinked 510(k)
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 49 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 49 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 51 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 52 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 53 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 52 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 53 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 55 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 41 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 56 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 58 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 61 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 61 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 68 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 68 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed
Mar 20, 2008Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Terminated
KWLNone listed

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