510(k) · Cleared
ClearedCorin Bipolar Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin Orthopedic Products · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Aug 9, 1993 after a 263-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 63 later devices descend from it.
- Decided
- Aug 9, 1993
- Review
- 263 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 2 citing it directly.
- This deviceK925897 Corin Bipolar ProsthesisCorin Orthopedic Products · 1993
- Descendant · cites it directly · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 2 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 3 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 4 generations on · 26 of its ownK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · cites it directly61descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 2 generations on48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 3 generations on38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 3 generations on27descendants
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925897 | Corin Bipolar Prosthesis | Corin Orthopedic Products | 1993 | — |
| +1 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +3 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +3 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +4 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (63)
See all 632 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, K120362 (Corin USA, 2012) has gone furthest, with 61 descendants of its own.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K925897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925897: Corin Bipolar Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925897
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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