510(k) · Cleared
ClearedLOSPA TKR 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 9, 2021 as substantially equivalent to K110404 (Corentec Co., Ltd., 2012) and 4 other predicates after a 163-day review. Its family tree reaches back 13 generations to 1994.
- Decided
- Dec 9, 2021
- Review
- 163 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K943462 (1994). 117 ancestors in all, the oldest K870730 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 9 generations between
- 3 generations backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- 2 generations backK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- 1 generation backK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020
- This deviceK212034 LOSPA TKR SystemCorentec Co., Ltd. · 2021
Show all 13 generations
- Root · 13 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 12 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 11 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 10 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 9 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 8 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 7 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 6 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 5 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 4 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- 3 generations backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- 2 generations backK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- 1 generation backK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020
- This deviceK212034 LOSPA TKR SystemCorentec Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −12 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −11 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −10 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −9 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −8 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −7 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −6 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| −5 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| −4 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| −3 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| −2 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| −1 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020 | — |
| 0 (this device) | K212034 | LOSPA TKR System | Corentec Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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…INTENDED USE The intended use of the added specification has not changed as a result of the modification of the predicate device cleared under LOSPA Total Knee System, K110404 & K130673 & K160157 & K192507 & K200395. The LOSPA Total Knee Replacement System is intended for use in total knee arthroplasty… | 2012 |
| * | K130673 | Lospa Total Knee Replacement SystemSummary page 5…SE The intended use of the added specification has not changed as a result of the modification of the predicate device cleared under LOSPA Total Knee System, K110404 & K130673 & K160157 & K192507 & K200395. The LOSPA Total Knee Replacement System is intended for use in total knee arthroplasty surgery fo… | 2013 |
| * | K160157 | LOSPA Modular Knee SystemSummary page 5…ntended use of the added specification has not changed as a result of the modification of the predicate device cleared under LOSPA Total Knee System, K110404 & K130673 & K160157 & K192507 & K200395. The LOSPA Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the foll… | 2016 |
| * | K192507 | LOSPA II Knee SystemSummary page 5…e of the added specification has not changed as a result of the modification of the predicate device cleared under LOSPA Total Knee System, K110404 & K130673 & K160157 & K192507 & K200395. The LOSPA Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indi… | 2019 |
| * | K200395 | LOSPA II Knee System (EXULT Knee Replacement System)Summary page 5…dded specification has not changed as a result of the modification of the predicate device cleared under LOSPA Total Knee System, K110404 & K130673 & K160157 & K192507 & K200395. The LOSPA Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications:… | 2020 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 58 of the 117 ancestors have a recall of any class.
- 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. 2021, 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 TKR 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.
LOSPA TRK System is intended for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212034 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212034: LOSPA TKR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212034
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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