# K060569: Balanced Knee System Modular Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jul 6, 2006 after 125 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: 4 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 11, 2014 · Class II · Z-2257-2014: Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back int
- Jan 7, 2011 · Not classified · Z-1740-2011: Components of a replacement knee system could be mislabeled.
- Jan 7, 2011 · Not classified · Z-1741-2011: Components of a replacement knee system could be mislabeled.
- Jan 7, 2011 · Not classified · Z-1742-2011: Components of a replacement knee system could be mislabeled.

## Indications for use
The Balanced Knee® System Revision is intended for cemented use only in knee arthroplasty procedures whose indications include: 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. Moderate valgus, varus, or flexion deformities. 6. Revision procedures where other treatments or devices have failed The Balanced Knee® System Revision is indicated in the salvage of previously failed surgical attempts where femoral bone loss may require the use of augments or stem extensions.

Source page: https://510kreport.com/device/K060569
Methodology: https://510kreport.com/methodology