510(k) · Cleared
Recalled · Class II · 2024Lospa Total 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 15, 2013 as substantially equivalent to K110404 (Corentec Co., Ltd., 2012) and 2 other predicates after a 34-day review. Its family tree reaches back 6 generations to 1987. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 15, 2013
- Review
- 34 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 6 generations to K870730 (1987). 16 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 5 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 4 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 3 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 2 generations backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- 1 generation backK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- This deviceK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- Descendant · 2 generations on · 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 · 3 generations on · 0 of its ownK250889 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242401 EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192507LOSPA II Knee SystemCorentec Co., Ltd. · 2019 · cites it directly7descendants
- K242046EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024 · 2 generations on2descendants
- K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020 · cites it directly2descendants
- K250889EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025 · 3 generations on0descendants
- K242401EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −5 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −4 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −3 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −2 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| −1 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| 0 (this device) | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | — |
| +1 | K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 | — |
| +2 | K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 | — |
| +1 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020 | — |
| +3 | K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025 | — |
| +2 | 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 |
| 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110404 | Eaum Total Knee SystemSummary page 2…nt System is intended for cemented use only. DEVICE DESCRIPTION The LOSPA TKR System specification inclusions are components of "LOSPA Total Knee System" cleared under K1 10404 & K 121037 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation - LOSP… | 2012 |
| * | K121037 | Lospa Tibial Base PlateSummary page 1…The intended use oJ the added specification has not changed (is a result of the modijfication of the predicate device cleared under Lospa Total Knee System, KI 10404 & K12 1037. Corentec Co. Ltd… | 2012 |
| * | K030978 | Scorpio NRG Knee SystemSummary page 3…110404 * Corentec Co., Ltd., LOSPA Tibial Base Plate, cleared under K 121037 * Howmedica Osteonics Corp. (Stryker) Scorpio 'NRC' Knee cleared uinder K030978 PERFORMANCE TESTING Performnance testing - Bench, was not required since engineering analysis showed that the inclusion of addi… | 2003 |
What descends from it? (9)
4 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)
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 26 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K192507 (Corentec Co., Ltd., 2019) has gone furthest, with 7 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. 2013, 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 Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications: * 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…
Read the full statement (98 words)
The Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications:
* 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 LOSPA Total Knee Replacement System is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130673: Lospa Total 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/K130673
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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