# K032641: Modification to: the Margron Hip Replacement System - Pathway: 510(k) (Special) - Applicant: Portland Orthopaedics Pty., Ltd. - Decided: Jan 20, 2004 after 146 days - Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate) - Device class: 2 - Regulation: 21 CFR 888.3353 - Recalls of this device: 71 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K851422 (1985). 9 ancestors in all. No later device cites it as a predicate yet. 0 of 10 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K992815: The Margron Hip Replacement System, Portland Orthopaedics Pty., Ltd. (2000) Summary page 3. ## Recalls of this device - Jan 11, 2008 · Not classified · Z-1944-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-2000-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1969-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1967-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1933-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1956-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1994-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1983-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1948-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1959-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1958-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1982-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1993-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1941-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1965-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1940-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1985-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1972-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1999-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1946-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1938-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1968-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1957-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1951-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1970-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1960-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1988-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1975-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1945-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1961-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1936-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1996-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1932-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1976-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1971-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1964-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1992-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1962-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1998-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1954-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1966-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1949-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1977-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1995-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1991-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1990-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1931-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1950-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-1986-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. - Jan 11, 2008 · Not classified · Z-2001-2008: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. ## Indications for use The MARGRONTM Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: * Osteoarthritis * Rheumatoid arthritis * Tumor conditions involving the upper third of the femur or the acetablum * Ankylosing spondylitis * Psoriatic arthritis * Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and C-reactive protein * Non union of femoral neck fracture or avascular necrosis of the femoral head * Post-traumatic fracture/dislocation of the hip * Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling * Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present * Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty. Source page: https://510kreport.com/device/K032641 Methodology: https://510kreport.com/methodology