510(k) · Cleared
ClearedUnity Knee PS-C Tibial Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 26, 2024 as substantially equivalent to K111184 (Omni Life Science, Inc., 2011) and 1 other predicate after an 89-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 26, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943462 (1994). 26 ancestors in all, the oldest K915192 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 4 generations backK060192 Apex Knee SystemOmni Life Science, Inc. · 2006 · Recalled
- 3 generations backK073602 Modification to: Apex Knee SystemOmnlife Science · 2008
- 2 generations backK102578 Apex PS Knee SystemOmni Life Science, Inc. · 2011
- 1 generation backK111184 Apex PS Knee System - PS-C InsertOmni Life Science, Inc. · 2011
- This deviceK240875 Unity Knee PS-C Tibial InsertCorin U.S.A. Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −4 | K060192 | Apex Knee System | Omni Life Science, Inc. | 2006 | 1 |
| −3 | K073602 | Modification to: Apex Knee System | Omnlife Science | 2008 | — |
| −2 | K102578 | Apex PS Knee System | Omni Life Science, Inc. | 2011 | — |
| −1 | K111184 | Apex PS Knee System - PS-C Insert | Omni Life Science, Inc. | 2011 | — |
| 0 (this device) | K240875 | Unity Knee PS-C Tibial Insert | Corin U.S.A. Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K111184 | Apex PS Knee System - PS-C InsertSummary page 5…560 Product Code(s): JWH Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K111184 Apex PS Knee System, PS-C Insert JWH, MBH K113060 Unity Total Knee… | 2011 |
| * | K113060 | Unity Toatal Knee SystemSummary page 5…rade Name (Primary Predicate is listed first) Product Code K111184 Apex PS Knee System, PS-C Insert JWH, MBH K113060 Unity Total Knee System JWH Device Description Summary The Unity Total… | 2012 |
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 30 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 15 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K111184.
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. 2024, 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 Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee System, in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. The General total knee arthroplasty indications include: • Painful, disabling joint disease of the knee resulting from: degenerative…
Read the full statement (177 words)
The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee System, in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The General total knee arthroplasty indications include:
• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic 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
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabiIized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity Total Knee System is intended for cemented use, single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240875: Unity Knee PS-C Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240875
Report an extraction error
Are you the manufacturer?
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