510(k) · Cleared
Recalled · Class II · 2024LOSPA Modular 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 1, 2016 as substantially equivalent to K960279 (Zimmer, Inc., 1996) and 1 other predicate after a 314-day review. Its family tree reaches back 2 generations to 1992. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 1, 2016
- Review
- 314 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915192 (1992). 7 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 1 generation backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- This deviceK160157 LOSPA Modular Knee SystemCorentec Co., Ltd. · 2016
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| −2 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −1 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| 0 (this device) | K160157 | LOSPA Modular Knee System | Corentec Co., Ltd. | 2016 | — |
| +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 |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 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 |
| 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? (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 |
|---|---|---|---|
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 8…510(k) Type or Model Name Primary Zimmer NexGen LCCK K960279 Additional Stryker Scorpio TS K994128 Following devices are used as reference devices,… | 1996 |
| * | K994128 | Scorpio Total Stablizer (TS) Total Knee SystemSummary page 8…or Model Name Primary Zimmer NexGen LCCK K960279 Additional Stryker Scorpio TS K994128 Following devices are used as reference devices, Manufacturer Trade or Proprietary or Model Name 510(k… | 2000 |
| † | K962137 | Genesis II Constrained System | 1996 |
| † | K023667 | RT-Plus Solution & RT-Plus Modular Solution Knee | 2002 |
| † | K102437 | GMK Revision Knee System | 2010 |
| † | K030978 | Scorpio NRG Knee System | 2003 |
| † | K060515 | Depuy PFC Sigma Knee Prosthesis | 2006 |
| † | K110404 | Eaum Total Knee System | 2012 |
What descends from it? (8)
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 24 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K192507 (Corentec Co., Ltd., 2019) has gone furthest, with 7 descendants of its own.
- 12 other devices also cite its predicate K960279.
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. 2016, 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 Modular 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.
The LOSPA Knee System is intended for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160157 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160157: LOSPA Modular Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160157
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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