# K131409: Cas Psi Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft, Inc.
- Decided: Sep 13, 2013 after 121 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121640: Zimmer Patient Specific Instruments System, Materialise NV (2012) Summary page 1.
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments, Materialise NV (2011) Summary page 1.

## Most influential descendants
- K171269: X-PSI Knee System (2017), 1 descendant of its own
- K230850: United Orthopedic Knee Patient Specific Instrumentation (2023), 0 descendants of its own

## Recalls of this device
- Nov 3, 2014 · Class II · Z-0495-2015: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K131409
Methodology: https://510kreport.com/methodology