510(k) · Cleared
ClearedDepuy Cemented Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 10, 1994 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.
- Decided
- Nov 10, 1994
- Review
- 176 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 3 citing it directly.
- This deviceK942370 Depuy Cemented Hip ProsthesisDepuy, Inc. · 1994
- Descendant · cites it directly · 36 of its ownK013352 Summit Cemented Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- Descendant · 2 generations on · 29 of its ownK023453 Depuy Summit FX Cemented Hip ProsthesisDePuy Orthopaedics, Inc. · 2002
- Descendant · 2 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 3 generations on · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- Descendant · 4 generations on · 15 of its ownK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K013352Summit Cemented Hip ProsthesisDePuy Orthopaedics, Inc. · 2001 · cites it directly36descendants
- K023453Depuy Summit FX Cemented Hip ProsthesisDePuy Orthopaedics, Inc. · 2002 · 2 generations on29descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 2 generations on27descendants
- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · 3 generations on20descendants
- K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942370 | Depuy Cemented Hip Prosthesis | Depuy, Inc. | 1994 | — |
| +1 | K013352 | Summit Cemented Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| +2 | K023453 | Depuy Summit FX Cemented Hip Prosthesis | DePuy Orthopaedics, Inc. | 2002 | — |
| +2 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +3 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| +4 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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? (38)
See all 383 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, K013352 (DePuy Orthopaedics, Inc., 2001) has gone furthest, with 36 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/K942370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942370: Depuy Cemented Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942370
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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