510(k) · Cleared
ClearedEXULT Knee Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Apr 17, 2025 as substantially equivalent to K242046 (Corentec Co., Ltd., 2024) after a 23-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Apr 17, 2025
- Review
- 23 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K870730 (1987). 38 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 5 generations between
- 3 generations backK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- 2 generations backK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- 1 generation backK242046 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
- This deviceK250889 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 8 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 7 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 6 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 5 generations backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- 4 generations backK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- 3 generations backK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- 2 generations backK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- 1 generation backK242046 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
- This deviceK250889 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −8 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −7 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −6 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −5 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| −4 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| −3 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
| −2 | K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 | — |
| −1 | K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 | — |
| 0 (this device) | K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242046 | EXULT Knee Replacement SystemSummary page 5…Product Codes: JWH Classification Panel: Orthopedic Products Panel Predicate device EXULT Knee Replacement System, Corentec Co., Ltd. (K242046) Device Description The purpose of this submission is to introduce EXULT Tibial Insert UCR (Ultra Congruent & Cruciate Retainin… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 17 of the 38 ancestors have a recall of any class.
- 1 other device also cites its predicate K242046.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
EXULT Knee Replacement System is indicated for the treatment of diseases as follows:
Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
The EXULT Knee Replacement System is intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250889: EXULT Knee Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250889
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026