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 Sep 12, 2024 as substantially equivalent to K192507 (Corentec Co., Ltd., 2019) and 1 other predicate after a 30-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Sep 12, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
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 deviceK242401 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
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 deviceK242401 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
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) | 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 |
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? (2)
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, K242046). Reference device: LOSPA Total Knee System, Corentec Co., Ltd. (K110404, K121037, K130673) Genesis II Total Knee Syste… | 2019 |
| * | K242046 | EXULT Knee Replacement SystemSummary page 5…Classification Panel: Orthopedic Products Panel Predicate device Primary predicate device: EXULT Knee Replacement System, Corentec Co., Ltd. (K192507, K242046). Reference device: LOSPA Total Knee System, Corentec Co., Ltd. (K110404, K121037, K130673) Genesis II Total Knee System, Smith… | 2024 |
| † | K110404 | Eaum Total Knee System | 2012 |
| † | K121037 | Lospa Tibial Base Plate | 2012 |
| † | K130673 | Lospa Total Knee Replacement System | 2013 |
| † | K071071 | Crosslinked Polyethylene Articular Inserts | 2007 |
| † | K951987 | Genesis II Total Knee System | 1995 |
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 37 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.
- 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 intended 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242401: 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/K242401
Report an extraction error
Are you the manufacturer?
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