510(k) K032641 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
| Applicant | Portland Orthopaedics Pty. , Ltd., Matraville Nsw, AU |
| Decision | Substantially Equivalent, Jan 20, 2004 |
| Received | Aug 27, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck Z, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-747-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck AZ, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-750-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-654-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck B, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-656-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck C, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-658-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck CB+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-685-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck B-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-686-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck C-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-687-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck C-B, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-688-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck B+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-689-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral neck C+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-690-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-726-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-727-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-647-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-648-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-649-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-650-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-651-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-652-000. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-061. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-062. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-071. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-072. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-011. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-012. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-021. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-022. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-031. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-032. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-041. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-042. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-051. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-052. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-061. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-062. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-963. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-964. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-965. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-973. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-974. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-975. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-913. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-914. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-915. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-923. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-924. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-925. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-933. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-934. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-935. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-943. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-944. Product is used for Orthopedic surgery. Product Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-945. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-953. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-954. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-955. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-956. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-963. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-964. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-965. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-966. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module AA6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-201. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module AA7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-202. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module BB7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-204. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module CC7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-205. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module YY6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-005. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module YY7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-006. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module ZZ6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-007. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module ZZ7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-008. Product is used for Orthopedic surgery. Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.