510(k) · Cleared
ClearedS-Rom ZT HA Proximal Femoral Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joint Medical Products Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Dec 30, 1991 after a 193-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 30, 1991
- Review
- 193 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK912713 S-Rom ZT HA Proximal Femoral SleeveJoint Medical Products Corp. · 1991
- Descendant · cites it directly · 2 of its ownK980020 Activelock Modular Femoral Hip SystemMetagen, LLC · 1998
- Descendant · cites it directly · 1 of its ownK992815 The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK032641 Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K980020Activelock Modular Femoral Hip SystemMetagen, LLC · 1998 · cites it directly2descendants
- K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · cites it directly1descendant
- K032641Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912713 | S-Rom ZT HA Proximal Femoral Sleeve | Joint Medical Products Corp. | 1991 | — |
| +1 | K980020 | Activelock Modular Femoral Hip System | Metagen, LLC | 1998 | — |
| +1 | K992815 | The Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2000 | 71 |
| +2 | K032641 | Modification to: the Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2004 | 71 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980020 (Metagen, LLC, 1998) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K912713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912713: S-Rom ZT HA Proximal Femoral Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912713
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026