510(k) · Cleared
ClearedExeter II Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 7, 1989 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.
- Decided
- Jun 7, 1989
- Review
- 84 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
53 later devices descend from it, 4 citing it directly.
- This deviceK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
- Descendant · cites it directly · 45 of its ownK974054 Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 44 of its ownK980843 Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998
- Descendant · 2 generations on · 25 of its ownK982918 Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998
- Descendant · 3 generations on · 23 of its ownK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- Descendant · 4 generations on · 14 of its ownK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K974054Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997 · cites it directly45descendants
- K980843Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998 · 2 generations on44descendants
- K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998 · 2 generations on25descendants
- K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004 · 3 generations on23descendants
- K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891454 | Exeter II Total Hip System | Howmedica Corp. | 1989 | — |
| +1 | K974054 | Distal Centralizer, Exeter II Hip System | Howmedica, Inc. | 1997 | 3 |
| +2 | K980843 | Exeter Intramedullary Bone Plug | Howmedica, Inc. | 1998 | — |
| +2 | K982918 | Depuy C-Stem System | DePuy Orthopaedics, Inc. | 1998 | — |
| +3 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| +4 | K082239 | Depuy C-Stem Amt | DePuy Orthopaedics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 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? (53)
See all 534 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, K974054 (Howmedica, Inc., 1997) has gone furthest, with 45 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/K891454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K891454: Exeter II Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891454
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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