# K131337: Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Oct 11, 2013 after 155 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: 7 generations back to K810258 (1981). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 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.
- K123457: Balanced Knee System High Flex PS, Ortho Development Corp. (2013) Summary page 2.
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 2.

## Most influential descendants
- 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 kneeO System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthropiasty 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/K131337
Methodology: https://510kreport.com/methodology