510(k) · Cleared
Recalled · Class II · 2024Eaum Total Knee 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 Feb 16, 2012 as substantially equivalent to K060515 (DePuy Orthopaedics, Inc., 2006) and 2 other predicates after a 367-day review. Its family tree reaches back 4 generations to 1987. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 16, 2012
- Review
- 367 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K870730 (1987). 14 ancestors in all. 14 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 3 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 2 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 1 generation backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- This deviceK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012
- Descendant · cites it directly · 10 of its ownK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- Descendant · cites it directly · 9 of its ownK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- Descendant · cites it directly · 7 of its ownK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK170753 Acculoc Total Knee SystemRootloc Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK242046 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K121037Lospa Tibial Base PlateCorentec Co., Ltd. · 2012 · cites it directly10descendants
- K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · cites it directly9descendants
- K192507LOSPA II Knee SystemCorentec Co., Ltd. · 2019 · cites it directly7descendants
- K170753Acculoc Total Knee SystemRootloc Co., Ltd. · 2018 · cites it directly3descendants
- K242046EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −3 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −2 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | — |
| +1 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| +1 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
| +1 | K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 | — |
| +1 | K170753 | Acculoc Total Knee System | Rootloc Co., Ltd. | 2018 | — |
| +2 | K242046 | 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 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K060515 | Depuy PFC Sigma Knee ProsthesisSummary page 2…evices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: DePuy Orthopaedics, Inc., DePuy Sigma Knee Femoral Adapter, K060515; Howmedica Osteonics Corp., Triathlon Total Knee System, K0535 14; and Howmedica Osteonics Corp., Scorpioo NRGTM Knee Sys… | 2006 |
| * | K053514 | Triathlon Total Knee SystemSummary page 2…equivalent to pre-amendment devices: DePuy Orthopaedics, Inc., DePuy Sigma Knee Femoral Adapter, K060515; Howmedica Osteonics Corp., Triathlon Total Knee System, K0535 14; and Howmedica Osteonics Corp., Scorpioo NRGTM Knee System Components, K030978. The EAUM Total Knee System and the predicate… | 2006 |
| * | K030978 | Scorpio NRG Knee SystemSummary page 2…Femoral Adapter, K060515; Howmedica Osteonics Corp., Triathlon Total Knee System, K0535 14; and Howmedica Osteonics Corp., Scorpioo NRGTM Knee System Components, K030978. The EAUM Total Knee System and the predicate devices are all patellofemoroltibial knee prosthesis systems, intended for cemente… | 2003 |
What descends from it? (14)
See all 148 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121037 | Lospa Tibial Base Plate | 2012 | 10 |
| K130673 | Lospa Total Knee Replacement System | 2013 | 9 |
| K192507 | LOSPA II Knee System | 2019 | 7 |
| K170753 | Acculoc Total Knee System | 2018 | 3 |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | 2020 | 2 |
| K231975 | PNK Total Knee System | 2023 | 0 |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | 2022 | 0 |
| K212034 | LOSPA TKR System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2024 | Class II | Z-1934-2024 | Labeling Change Control | Due to unsupported 10 year expiration date. |
| Mar 29, 2024 | Class II | Z-1935-2024 | Labeling Change Control | Due to unsupported 10 year expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K121037 (Corentec Co., Ltd., 2012) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K060515.
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. 2012, 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?
The EAUM Total Knee System is intended for use in total knee arthroplasty surgery for the following indications:*
Painful, disabling joint disease of the knee resulting from noninflamimatory 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 arthropiasty procedure.
The EAUM Total Knee System is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110404 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110404: Eaum Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110404
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