510(k) · Cleared
ClearedLOSPA II 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 Dec 11, 2019 as substantially equivalent to K110404 (Corentec Co., Ltd., 2012) and 4 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1987. 7 later devices descend from it.
- Decided
- Dec 11, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K870730 (1987). 36 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 6 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 5 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 4 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 3 generations backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- 2 generations backK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- 1 generation backK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- This deviceK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK242046 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020
- Descendant · 2 generations on · 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
- Descendant · cites it directly · 0 of its ownK222278 LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K242046EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024 · cites it directly2descendants
- K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020 · cites it directly2descendants
- K250889EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025 · 2 generations on0descendants
- K242401EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024 · cites it directly0descendants
- K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −6 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −5 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −4 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −3 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| −2 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| −1 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
| 0 (this device) | K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 | — |
| +1 | K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 | — |
| +1 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020 | — |
| +2 | K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025 | — |
| +1 | K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 | — |
| +1 | K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Corentec Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K110404 | Eaum Total Knee SystemSummary page 5…I Knee System DEVICE DESCRIPTION The subject LOSPA II Knee System components are similar to predicate devices, x LOSPA Total Knee System components cleared under K110404, K121037 & K130673 for subject devices - Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components… | 2012 |
| * | K121037 | Lospa Tibial Base PlateSummary page 5…stem DEVICE DESCRIPTION The subject LOSPA II Knee System components are similar to predicate devices, x LOSPA Total Knee System components cleared under K110404, K121037 & K130673 for subject devices - Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and relat… | 2012 |
| * | K130673 | Lospa Total Knee Replacement SystemSummary page 5…RIPTION The subject LOSPA II Knee System components are similar to predicate devices, x LOSPA Total Knee System components cleared under K110404, K121037 & K130673 for subject devices - Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentatio… | 2013 |
| * | K160157 | LOSPA Modular Knee SystemSummary page 5…ct devices - Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation. x LOSPA Modular Knee System cleared under K160157 for subject devices - Stemmed Tibial Base Plate and Stem Plug and related Instrumentation The subject components are a li… | 2016 |
| * | K101433 | Depuy Attune Knee SystemSummary page 6…System Predicate’s DePuy Orthopedics Attune Knee System K101433 Inc. Coren (Bencox) Total Reference Corentec Co. Ltd… | 2010 |
| † | K103431 | Coren Total Hip System | 2011 |
What descends from it? (7)
5 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 32 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 17 of the 36 ancestors have a recall of any class.
- Of its descendants, K242046 (Corentec Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K110404.
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. 2019, 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?
LOSPA II Knee 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.
LOSPA II Knee System is intended for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192507: LOSPA II Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192507
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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