# K233093: Balanced Knee® System TriMax PS Plus Tibial Insert

- Pathway: 510(k) (Special)
- Applicant: Ortho Development Corporation
- Decided: Oct 25, 2023 after 29 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: 8 generations back to K810258 (1981). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131337: Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella, Ortho Development Corp. (2013) Summary page 4.

## Indications for use
The Balanced Knee' System TriMax PS Plus Tibial Insert is indicated for use in cemented total knee arthroplasty procedures with the following indications: 1. Loss of knee joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K233093
Methodology: https://510kreport.com/methodology