# K180743: Balanced Knee Revision System - Offset Junction Box

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Jun 20, 2018 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K060569: Balanced Knee System Modular Revision Knee System, Ortho Development Corp. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
This device is intended for use in total knee arthroplasty procedures for the following conditions: 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/K180743
Methodology: https://510kreport.com/methodology