# K253161: Balanced Knee System TriMax Porous Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Dec 19, 2025 after 84 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152169: Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts, Ortho Development Corporation (2015) Summary page 5.
- K123457: Balanced Knee System High Flex PS, Ortho Development Corp. (2013) Summary page 5.

## Indications for use
Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications: 1. Loss of 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/K253161
Methodology: https://510kreport.com/methodology