# K133342: Arthrex Ibalance Tka System

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 17, 2013 after 48 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: 2 generations back to K962152 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081127: Accin Total Knee System, Accelerated Innovation, LLC (2008) Summary page 1.

## Indications for use
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for: * Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; * Post-traumatic loss of knee joint configuration and function; * Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; * Revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilized components: * Ligamentous instability requiring implant bearing surfaces with increased constraint; * Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K133342
Methodology: https://510kreport.com/methodology