510(k) · Cleared
Recalled · Class II · 2014Cas Psi Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 13, 2013 as substantially equivalent to K121640 (Materialise NV, 2012) and 1 other predicate after a 121-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 13, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073449 SurgicaseMaterialise NV · 2008
- 2 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 1 generation backK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- This deviceK131409 Cas Psi Knee SystemOrthosoft, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK171269 X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2017
- Descendant · 2 generations on · 0 of its ownK230850 United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −2 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −1 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| 0 (this device) | K131409 | Cas Psi Knee System | Orthosoft, Inc. | 2013 | — |
| +1 | K171269 | X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2017 | — |
| +2 | K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K121640 | Zimmer Patient Specific Instruments SystemSummary page 1…r Porous- Coated Uncemented Prosthesis / 21 CFR § 888.3565 Predicate Devices: 1. Zimmer Patient Specific Instruments System 5.0, Submitter: Materialise N.V., K12 1640 2. Zimmer Patient Specific Instruments System 2.5, Submitter: Materialise N.V., K1 11492 Device Description: The CAS PS… | 2012 |
| * | K111492 | Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsSummary page 1…nt Specific Instruments System 5.0, Submitter: Materialise N.V., K12 1640 2. Zimmer Patient Specific Instruments System 2.5, Submitter: Materialise N.V., K1 11492 Device Description: The CAS PSI Knee is an orthopedic instrument system indicated to assist in the positioning of knee replaceme… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171269 | X-PSI Knee System | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2014 | Class II | Z-0495-2015 | Software design | Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K171269 (Orthosoft Inc (D/B/A Zimmer Cas), 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K121640.
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 CAS PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of…
Read the full statement (135 words)
The CAS PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.
The CAS PSI Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, Nex~en CR-Flex, Nexgen CR-Flex Gender, Nexgen LPS, Nexgen LPS-Flex, Nexgen LPS-Flex Gender, Persona CR, and Persona PS.
The patient specific guide components are intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131409: Cas Psi 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/K131409
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