Portland Orthopaedics Pty., Ltd.
Country not established
- Devices
- 5
- FDA recalls
- 71
At a glance
Market reach
- United States
- FDA recalls
What Portland Orthopaedics Pty., Ltd. makes
Portland Orthopaedics designs and manufactures ceramic-on-ceramic and modular hip replacement components, including femoral heads, acetabular cup systems, and stemmed hip prostheses. Their portfolio includes the Portland Ceramic femoral head (Biolox-Forte), the M-Cor and Equator Plus acetabular cup systems, and the Margron hip replacement system with modular upgrades.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Portland Ceramic (Biolox-Forte) Femoral Head Ref K061564
Regimes: 510(k) Registry: 510(k)M-Cor Hip Replacement System Ref K053417
Regimes: 510(k) Registry: 510(k)Equator Plus Acetabular Cup System Ref K051844
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
The Margron Hip Replacement System Ref K992815
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 71 recalls initiated by Portland Orthopaedics Pty., Ltd., initiated on 2008-01-11. By recorded status: 71 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 11 Jan 2008 Z-1931-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1932-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1933-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1934-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1935-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1936-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1937-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1938-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1939-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1940-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
Show the 25 most recent of 71 recalls
2008
- 11 Jan 2008 Z-1941-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1942-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1943-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1944-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1945-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1946-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1947-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1948-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1949-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1950-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1951-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1952-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1953-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1954-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- 11 Jan 2008 Z-1955-2008 Unclassified (pre-2012) Terminated Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
Frequently asked questions
How many devices does Portland Orthopaedics Pty., Ltd. have in the registry?
The registry currently lists 5 devices for Portland Orthopaedics Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Portland Orthopaedics Pty., Ltd.'s devices?
Among its 5 most recently registered devices, Portland Orthopaedics Pty., Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Portland Orthopaedics Pty., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Portland Orthopaedics Pty., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Portland Orthopaedics Pty., Ltd.?
FDA recall records list 71 recalls initiated by Portland Orthopaedics Pty., Ltd., the most recent initiated on 11 Jan 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Portland Orthopaedics Pty., Ltd. in the registry?
The most recently registered devices listed for Portland Orthopaedics Pty., Ltd. include PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD, M-COR HIP REPLACEMENT SYSTEM, EQUATOR PLUS ACETABULAR CUP SYSTEM and MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM.