510(k) · Cleared
ClearedEsop CO-CR Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 12, 2002 as substantially equivalent to K953977 (Ortho Development Corp., 1996) and 2 other predicates after a 68-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Jun 12, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K881288 (1988). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- 2 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
- 1 generation backK010081 Acumatch L-Series Unipolar EndoprosthesisExactech, Inc. · 2001
- This deviceK021109 Esop CO-CR Femoral HeadsFournitures Hospitalieres · 2002
- Descendant · cites it directly · 0 of its ownK050556 Alumina HeadFournitures Hospitalieres Industrie · 2005
Most influential descendants
Showing 1 of 1 · See all- K050556Alumina HeadFournitures Hospitalieres Industrie · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| −2 | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| −1 | K010081 | Acumatch L-Series Unipolar Endoprosthesis | Exactech, Inc. | 2001 | — |
| 0 (this device) | K021109 | Esop CO-CR Femoral Heads | Fournitures Hospitalieres | 2002 | — |
| +1 | K050556 | Alumina Head | Fournitures Hospitalieres Industrie | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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…us- coated uncemented prosthesis Predicate Device: HeadlocTMFemoral Head Primaloc8 Cementless Hip System (K953977) Ortho Development Corporation Intrinsic8 Cementless Total Hip System (K92… | 1996 |
| * | K923911 | Intrinsic StemSummary page 1…Primaloc8 Cementless Hip System (K953977) Ortho Development Corporation Intrinsic8 Cementless Total Hip System (K923911) Ortho Max. Inc. Exactech AcuMatch Hip System (KO10081) Device descriptio… | 1993 |
| * | K010081 | Acumatch L-Series Unipolar Endoprosthesis | 2001 |
| * | — | Headloc Femoral Head Named without a submission number |
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 |
|---|---|---|---|
| K050556 | Alumina Head | 2005 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K050556 (Fournitures Hospitalieres Industrie, 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K953977.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The ESOP@Co-Cr Femoral Heads are 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 as stated in the FDA summary.
https://510kreport.com/device/K021109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021109: Esop CO-CR Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021109
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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