510(k) · Cleared
Recalled · 2008Modification to: the Margron Hip Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portland Orthopaedics Pty., Ltd. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jan 20, 2004 as substantially equivalent to K992815 (Portland Orthopaedics Pty., Ltd., 2000) after a 146-day review. Its family tree reaches back 3 generations to 1985. It has been recalled 71 times.
- Decided
- Jan 20, 2004
- Review
- 146 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 71
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851422 (1985). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851422 S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipJoint Medical Products Corp. · 1985
- 2 generations backK980020 Activelock Modular Femoral Hip SystemMetagen, LLC · 1998
- 1 generation backK992815 The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · Recalled
- This deviceK032641 Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851422 | S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip | Joint Medical Products Corp. | 1985 | — |
| −2 | K980020 | Activelock Modular Femoral Hip System | Metagen, LLC | 1998 | — |
| −1 | K992815 | The Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2000 | 71 |
| 0 (this device) | K032641 | Modification to: the Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1994 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992815 | The Margron Hip Replacement SystemSummary page 3…Page 17 Substantial Equivalence: The MARGRONTm Hip Replacement System is substantially equivalent to the current MARGRONT m Hip Replacement System (K992815) in that: * the intended use is the same · the same operating principles is used * the same final design configur… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2008 | Not classified | Z-1944-2008 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (175 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032641: Modification to: the Margron Hip Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032641
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026