510(k) · Cleared
ClearedExeter 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 Feb 10, 1981 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Feb 10, 1981
- Review
- 60 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK803126 Exeter Total Hip SystemHowmedica Corp. · 1981
- Descendant · cites it directly · 7 of its ownK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK142761 Corin TaperFit Hip StemCorin USA · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd. · 2016 · cites it directly7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 3 generations on4descendants
- K142761Corin TaperFit Hip StemCorin USA · 2015 · cites it directly4descendants
- K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K803126 | Exeter Total Hip System | Howmedica Corp. | 1981 | — |
| +1 | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with… | Corentec Co., Ltd. | 2016 | 1 |
| +2 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +3 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +1 | K142761 | Corin TaperFit Hip Stem | Corin USA | 2015 | 1 |
| +3 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (13)
See all 132 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, K152084 (Corentec Co., Ltd., 2016) has gone furthest, with 7 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/K803126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K803126: Exeter Total 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/K803126
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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