Portland Orthopaedics Pty., Ltd.
Matraville Nsw, AU
Portland Orthopaedics Pty. , Ltd. appears in FDA device records in Matraville Nsw, AU. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 71 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Portland Orthopaedics Pty., Ltd. between 2000 and 2007. The busiest year on record is 2006, with 2. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K063278 | PORTLAND COBALT CHROME FEMORAL HEAD | JDI | Substantially Equivalent | |
| K061564 | PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD | LZO | Substantially Equivalent | |
| K053417 | M-COR HIP REPLACEMENT SYSTEM | LPH | Substantially Equivalent | |
| K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM | MAY | Substantially Equivalent | |
| K032641 | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM | MEH | Substantially Equivalent | |
| K992815 | THE MARGRON HIP REPLACEMENT SYSTEM | MEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Recall records
Showing 25 of 71| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2001-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-2000-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1999-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1998-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1997-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1996-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1995-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1994-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1993-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1992-2008 | Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-966. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1991-2008 | Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-965. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1990-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1989-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1988-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1987-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1986-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1985-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1984-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1983-2008 | 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 is used for Orthopedic surgery. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1982-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1981-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1980-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1979-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1978-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated | ||
| Z-1977-2008 | 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. | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain