510(k) · Cleared
ClearedEsop S/C 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 Mar 5, 1998 as substantially equivalent to K953977 (Ortho Development Corp., 1996) and 1 other predicate after a 455-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Mar 5, 1998
- Review
- 455 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923911 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K021108Esop HA Femoral StemFournitures Hospitalieres · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923911 | Intrinsic Stem | Turnkey Intergration USA, Inc. | 1993 | — |
| 0 (this device) | K964878 | Esop S/C Femoral Stem | Fournitures Hospitalieres | 1998 | — |
| +1 | K021108 | Esop HA Femoral Stem | Fournitures Hospitalieres | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K953977 | Primaloc Cementless Hip SystemSummary page 1….95 (+33) 98.53.42.13 December 5, 1996 ESOP® S/C Femoral Stem Hip Stem Prosthesis, Hip, Femoral Component (Metal Stem - Ceramic Head) Primaloc® Cementless Hip System (K953977), Ortho Development Corporation; Intrinsic® Cementless Total Hip System (K923911), Ortho Max, Inc. The ESOP® S/C Femoral Stem c… | 1996 |
| * | K923911 | Intrinsic StemSummary page 1…s, Hip, Femoral Component (Metal Stem - Ceramic Head) Primaloc® Cementless Hip System (K953977), Ortho Development Corporation; Intrinsic® Cementless Total Hip System (K923911), Ortho Max, Inc. The ESOP® S/C Femoral Stem consists of a ceramic head, left and right configuration metaphysary parts in vario… | 1993 |
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 |
|---|---|---|---|
| K021108 | Esop HA Femoral Stem | 2002 | 0 |
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?
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® S/C Femoral Stem is a device 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 exists 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/K964878 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964878: Esop S/C Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964878
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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