# K992815: The Margron Hip Replacement System - Pathway: 510(k) (Traditional) - Applicant: Portland Orthopaedics Pty., Ltd. - Decided: Feb 7, 2000 after 171 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: 2 generations back to K851422 (1985). 8 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 10 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K980020: Activelock Modular Femoral Hip System, Metagen, LLC (1998) Summary page 1. - K921181: Mallory-Head Total Hip System, Biomet, Inc. (1994) Summary page 1. - K942027: Impact CO-CR 1-Piece Femoral Component, Biomet, Inc. (1994) Summary page 1. - K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip, Joint Medical Products Corp. (1985) Summary page 1. - K912713: S-Rom ZT HA Proximal Femoral Sleeve, Joint Medical Products Corp. (1991) Summary page 1. - K913231: S-Rom (TM) Total Lhip System W/Ceramic Head, Joint Medical Products Corp. (1991) Summary page 1. - K942115: Infinity Revision Hip Stem, Wrightmedicaltechnologyinc (1994) Summary page 1. - K912593: Modular Hip System, Smith & Nephew Richards, Inc. (1991) Summary page 1. ## Most influential descendants - K032641: Modification to: the Margron Hip Replacement System (2004), 0 descendants of its own ## 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 Margron™ 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 Ankylosing spondylitis Psoriatic arthritis Old osteomyelitis - with a long infection free period and a normal WBC, C-Reactive protein and ESR 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 uncemented or 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/K992815 Methodology: https://510kreport.com/methodology