510(k) · Cleared
ClearedLOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
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 Aug 26, 2022 as substantially equivalent to K160157 (Corentec Co., Ltd., 2016) and 2 other predicates after a 28-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Aug 26, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K870730 (1987). 37 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 7 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 6 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 5 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 4 generations backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- 3 generations backK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- 2 generations backK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- 1 generation backK192507 LOSPA II Knee SystemCorentec Co., Ltd. · 2019
- This deviceK222278 LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −7 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −6 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −5 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −4 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| −3 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| −2 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
| −1 | K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K160157 | LOSPA Modular Knee SystemSummary page 5…egally Marketed Device(s) to Which Equivalence is Claimed 510(k) Number Trade Name Submitter Product Code Primary K160157 LOSPA Modular Knee System JWH, MBH K192507 LOSPA II Knee System… | 2016 |
| * | K192507 | LOSPA II Knee SystemSummary page 5…Name Submitter Product Code Primary K160157 LOSPA Modular Knee System JWH, MBH K192507 LOSPA II Knee System JWH LOSPA Total Knee System… | 2019 |
| * | K110404 | Eaum Total Knee SystemSummary page 5…WH, MBH K192507 LOSPA II Knee System JWH LOSPA Total Knee System K110404 JWH (EAUM Total Knee System)… | 2012 |
| † | K130673 | Lospa Total Knee Replacement System | 2013 |
| † | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | 2020 |
| † | K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | 2020 |
| † | K212034 | LOSPA TKR System | 2021 |
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 35 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 17 of the 37 ancestors have a recall of any class.
- 3 other devices also cite its predicate K160157.
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. 2022, 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…
Read the full statement (180 words)
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 TKR System is intended for cemented application only.
EXULT 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.
EXULT Knee System is intended for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222278: LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222278
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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