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 Aug 1, 2024 as substantially equivalent to K192507 (Corentec Co., Ltd., 2019) after a 20-day review. Its family tree reaches back 8 generations to 1987. 2 later devices descend from it.
- Decided
- Aug 1, 2024
- Review
- 20 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K870730 (1987). 37 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 7 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 6 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 5 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 4 generations backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- 3 generations backK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- 2 generations backK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- 1 generation backK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- This deviceK242046 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK250889 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242401 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −7 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −6 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −5 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −4 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| −3 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| −2 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
| −1 | K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 | — |
| 0 (this device) | K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 | — |
| +1 | K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025 | — |
| +1 | K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K192507 | LOSPA II Knee SystemSummary page 5…JWH Classification Panel: Orthopedic Products Panel Predicate device Primary predicate device: EXULT Knee Replacement System, Corentec Co., Ltd. (K192507). Reference device: LOSPA Total Knee System, Corentec Co., Ltd. (K110404, K121037, K130673) Device Description The purpose of… | 2019 |
| † | K110404 | Eaum Total Knee System | 2012 |
| † | K121037 | Lospa Tibial Base Plate | 2012 |
| † | K130673 | Lospa Total Knee Replacement System | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 17 of the 37 ancestors have a recall of any class.
- Of its descendants, K250889 (Corentec Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K192507.
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. 2024, 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.
EXULT Knee Replacement System is intended for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242046: 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/K242046
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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