# K143047: Arthrex iBalance Patella Implant, Dome

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Nov 19, 2014 after 27 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 K962152 (1996). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133854: Arthrex Ibalance Tka System, Arthrex, Inc. (2014) Summary page 4.
- K081127: Accin Total Knee System, Accelerated Innovation, LLC (2008) Summary page 4.

## Most influential descendants
- K153586: Arthrex iBalance TKA System (2016), 1 descendant of its own
- K171365: Arthrex Knee Systems (2017), 0 descendants of its own

## 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 posteriorily 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/K143047
Methodology: https://510kreport.com/methodology