510(k) · Cleared
ClearedOsteonics Ecsi Hip Stem Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 21, 1990 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.
- Decided
- Mar 21, 1990
- Review
- 27 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 2 citing it directly.
- This deviceK900836 Osteonics Ecsi Hip Stem SeriesOsteonics Corp. · 1990
- Descendant · cites it directly · 55 of its ownK021310 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002
- Descendant · 2 generations on · 54 of its ownK061434 Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · Recalled
- Descendant · 3 generations on · 37 of its ownK110290 Exeter Hip StemHowmedica Osteonics Corp. · 2011 · Recalled
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 3 generations on · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K02131036MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · cites it directly55descendants
- K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · 2 generations on54descendants
- K110290Exeter Hip StemHowmedica Osteonics Corp. · 2011 · 3 generations on37descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900836 | Osteonics Ecsi Hip Stem Series | Osteonics Corp. | 1990 | — |
| +1 | K021310 | 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit) | Howmedica Osteonics Corp. | 2002 | — |
| +2 | K061434 | Trident Large Diameter Hip System | Howmedica Osteonics Corp. | 2006 | 2 |
| +3 | K110290 | Exeter Hip Stem | Howmedica Osteonics Corp. | 2011 | 1 |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +3 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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? (56)
See all 562 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, K021310 (Howmedica Osteonics Corp., 2002) has gone furthest, with 55 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K900836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900836: Osteonics Ecsi Hip Stem Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900836
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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