510(k) · Cleared
ClearedEsop HA Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on May 3, 2002 as substantially equivalent to K964878 (Fournitures Hospitalieres, 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- May 3, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923911 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923911 | Intrinsic Stem | Turnkey Intergration USA, Inc. | 1993 | — |
| −1 | K964878 | Esop S/C Femoral Stem | Fournitures Hospitalieres | 1998 | — |
| 0 (this device) | K021108 | Esop HA Femoral Stem | Fournitures Hospitalieres | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K964878 | Esop S/C Femoral StemSummary page 1…00 Christine Quendez +332 98556895 +33298534213 22 March 2002 ESOP® HA Femoral Stem Femoral Stem Prosthesis, Hip, Femoral Component e FHI ESOP® S/C Femoral Stem, K964878 e Landos CORAIL Femoral Stem, K953111 The ESOP® HA Femoral Stem consists of left and right configuration metaphysis parts in var… | 1998 |
| * | K953111 | CorailSummary page 1…+33298534213 22 March 2002 ESOP® HA Femoral Stem Femoral Stem Prosthesis, Hip, Femoral Component e FHI ESOP® S/C Femoral Stem, K964878 e Landos CORAIL Femoral Stem, K953111 The ESOP® HA Femoral Stem consists of left and right configuration metaphysis parts in various size diameters, and diaphysis par… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 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 ESOP® HA Femoral Stem is intended for use in degenerative and inflammatory
arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously
failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic
evidence shows there is sufficient sound bone to seat the prosthesis. This device is
intended for cementless application.
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/K021108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021108: Esop HA Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021108
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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