# K103837: Balanced Knee System Revision Offset Tibia

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development
- Decided: Mar 24, 2011 after 84 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: 3 generations back to K962137 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031201: Ortho Development Balanced Knee Modular Tibial System, Ortho Development Corp. (2003) Summary page 1.
- K010212: Offset Tibial Tray, Biomet, Inc. (2001) Summary page 1.
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 1.

## Indications for use
The Balanced Knee System Revision Offset Tibia is indicated for use in total knee arthroplasty procedures, for cemented use only. Total knee arthroplasty is indicated for the following conditions: 1. toss 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, dr flexion deformities. 6. Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K103837
Methodology: https://510kreport.com/methodology