510(k) · Cleared
Recalled · 2008The 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 Feb 7, 2000 as substantially equivalent to K980020 (Metagen, LLC, 1998) and 7 other predicates after a 171-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it. It has been recalled 71 times.
- Decided
- Feb 7, 2000
- Review
- 171 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 71
- Predicates
- 8
Its longest line of descent runs back 2 generations to K851422 (1985). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK851422 S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipJoint Medical Products Corp. · 1985
- 1 generation backK980020 Activelock Modular Femoral Hip SystemMetagen, LLC · 1998
- This deviceK992815 The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK032641 Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K032641Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851422 | S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip | Joint Medical Products Corp. | 1985 | — |
| −1 | K980020 | Activelock Modular Femoral Hip System | Metagen, LLC | 1998 | — |
| 0 (this device) | K992815 | The Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2000 | — |
| +1 | K032641 | Modification to: the Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2004 | 71 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1994 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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? (8)
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 |
|---|---|---|---|
| * | K980020 | Activelock Modular Femoral Hip SystemSummary page 1…e Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement System 510(k) Notification 02 Xk >5/5 >od 3 Device Description: The Margron™ hip… | 1998 |
| * | K921181 | Mallory-Head Total Hip SystemSummary page 1…et Medical/ Medical Richards J&J Technology System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement System 510(k) Notification 02 === Page 2 =… | 1994 |
| * | K942027 | Impact CO-CR 1-Piece Femoral ComponentSummary page 1…ded use to: Manufacturer Joint Wright S&N Metagen Biomet Medical/ Medical Richards J&J Technology System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip R… | 1994 |
| * | K851422 | S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipSummary page 1…nufacturer Joint Wright S&N Metagen Biomet Medical/ Medical Richards J&J Technology System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement Syst… | 1985 |
| * | K912713 | S-Rom ZT HA Proximal Femoral SleeveSummary page 1…Medical Richards J&J Technology System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement System 510(k) Notification 02 Xk >5/5… | 1991 |
| * | K913231 | S-Rom (TM) Total Lhip System W/Ceramic HeadSummary page 1…echnology System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement System 510(k) Notification 02 Xk >5/5 >od 3 Device Descripti… | 1991 |
| * | K942115 | Infinity Revision Hip StemSummary page 1…oint Wright S&N Metagen Biomet Medical/ Medical Richards J&J Technology System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement System 510(k) No… | 1994 |
| * | K912593 | Modular Hip SystemSummary page 1…System Name Modular Impact Mallory- S-ROM Infinity Modular Femoral | (K942027) Head (K851422, | (K942115) | Hip System Hip (K921181) | K912713, (RMHS) System K913231) (K912593) (K980020) The Margron Hip Replacement System 510(k) Notification 02 Xk >5/5 >od 3 Device Description: The M… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032641 | Modification to: the Margron Hip Replacement System | 2004 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K032641 (Portland Orthopaedics Pty., Ltd., 2004) has gone furthest, with 0 descendants of its own.
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 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 -…
Read the full statement (153 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992815 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992815: The Margron Hip Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992815
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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