# K123457: Balanced Knee System High Flex PS

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Mar 22, 2013 after 134 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: 1 generation back to K991581 (1999). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994370: Ortho Development Balanced Knee System, Ortho Development Corp. (2000) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.

## Most influential descendants
- K131337: Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella (2013), 3 descendants of its own
- K152169: Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts (2015), 1 descendant of its own
- K253161: Balanced Knee System TriMax Porous Femoral Components (2025), 0 descendants of its own
- K233093: Balanced Knee® System TriMax PS Plus Tibial Insert (2023), 0 descendants of its own

## Indications for use
The Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures. Total knee arthroplasty is indicated for the following conditions: 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/K123457
Methodology: https://510kreport.com/methodology