510(k) · Cleared
ClearedElite Modular Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thackray USA · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 8, 1988 after a 331-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.
- Decided
- Apr 8, 1988
- Review
- 331 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 3 citing it directly.
- This deviceK871867 Elite Modular Hip SystemThackray USA · 1988
- Descendant · cites it directly · 25 of its ownK982918 Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998
- Descendant · 2 generations on · 23 of its ownK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- Descendant · 3 generations on · 14 of its ownK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
- Descendant · 2 generations on · 14 of its ownK013350 Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001
- Descendant · 2 generations on · 8 of its ownK220216 C-Stem AMT LE ProsthesisDepuy Ireland UC · 2022
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998 · cites it directly25descendants
- K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004 · 2 generations on23descendants
- K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008 · 3 generations on14descendants
- K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001 · 2 generations on14descendants
- K220216C-Stem AMT LE ProsthesisDepuy Ireland UC · 2022 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871867 | Elite Modular Hip System | Thackray USA | 1988 | — |
| +1 | K982918 | Depuy C-Stem System | DePuy Orthopaedics, Inc. | 1998 | — |
| +2 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| +3 | K082239 | Depuy C-Stem Amt | DePuy Orthopaedics, Inc. | 2008 | — |
| +2 | K013350 | Modification to Depuy C-Stem System | DePuy Orthopaedics, Inc. | 2001 | — |
| +2 | K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (27)
See all 273 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, K982918 (DePuy Orthopaedics, Inc., 1998) has gone furthest, with 25 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/K871867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K871867: Elite Modular Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871867
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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