# K240875: Unity Knee PS-C Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Jun 26, 2024 after 89 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943462 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111184: Apex PS Knee System - PS-C Insert, Omni Life Science, Inc. (2011) Summary page 5.
- K113060: Unity Toatal Knee System, Corin USA (2012) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K240875
Methodology: https://510kreport.com/methodology