Atlas FDA

THE MARGRON HIP REPLACEMENT SYSTEM

FDA 510(k) clearance K992815 · decided 2000-02-07

Clearance details

K-number
K992815
Device name
THE MARGRON HIP REPLACEMENT SYSTEM
Applicant
Portland Orthopaedics Pty. , Ltd.
Decision
Substantially Equivalent
Date received
1999-08-20
Decision date
2000-02-07
Days to decision
171 days
Clearance type
Traditional
Product code
MEH
Device class
2
Regulation number
888.3353
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Kogarah, New South Wales, AU
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthop recall (Z-1931-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck Z, sterile, Portland Orthop recall (Z-1932-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck AZ, sterile, Portland Ortho recall (Z-1933-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck A, sterile, Portland Orthop recall (Z-1934-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck B, sterile, Portland Orthop recall (Z-1935-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck C, sterile, Portland Orthop recall (Z-1936-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck CB+6, sterile, Portland Ort recall (Z-1937-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck B-A, sterile, Portland Orth recall (Z-1938-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck C-A, sterile, Portland Orth recall (Z-1939-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck C-B, sterile, Portland Orth recall (Z-1940-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck B+4, sterile, Portland Orth recall (Z-1941-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral neck C+6, sterile, Portland Orth recall (Z-1942-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+0, sterile, Portland Orth recall (Z-1943-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+0, sterile, Portland Orth recall (Z-1944-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0, sterile, Portland Orth recall (Z-1945-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+0, sterile, Portland Orth recall (Z-1946-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+0, sterile, Portland Orth recall (Z-1947-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+0, sterile, Portland Orth recall (Z-1948-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+0, sterile, Portland Orth recall (Z-1949-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+0, sterile, Portland Orth recall (Z-1950-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1, sterile, Portland Orth recall (Z-1951-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+2, sterile, Portland Orth recall (Z-1952-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1, sterile, Portland Orth recall (Z-1953-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2, sterile, Portland Orth recall (Z-1954-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+1, sterile, Portland Orth recall (Z-1955-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2, sterile, Portland Orth recall (Z-1956-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile, Portland Orth recall (Z-1957-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+2, sterile, Portland Orth recall (Z-1958-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1, sterile, Portland Orth recall (Z-1959-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+2, sterile, Portland Orth recall (Z-1960-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+1, sterile, Portland Orth recall (Z-1961-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2, sterile, Portland Orth recall (Z-1962-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1, sterile, Portland Orth recall (Z-1963-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2, sterile, Portland Orth recall (Z-1964-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+1, sterile, Portland Orth recall (Z-1965-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+2, sterile, Portland Orth recall (Z-1966-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+3, sterile recall (Z-1967-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+4, sterile recall (Z-1968-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+5, sterile recall (Z-1969-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+3, sterile recall (Z-1970-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+4, sterile recall (Z-1971-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+5, sterile recall (Z-1972-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+3, sterile recall (Z-1973-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+4, sterile recall (Z-1974-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+5, sterile recall (Z-1975-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+3, sterile recall (Z-1976-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+4, sterile recall (Z-1977-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+5, sterile recall (Z-1978-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+3, sterile recall (Z-1979-2008)Portland Orthopaedics Pty, Ltd.2008-09-18
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+4, sterile recall (Z-1980-2008)Portland Orthopaedics Pty, Ltd.2008-09-18