# K141635: Arthrex Ibalance Tka System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 3, 2014 after 76 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 79 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 95 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 4.
- K121771: Zimmer Persona the Personalized Knee System, Zimmer, Inc. (2012) Summary page 4.

## Most influential descendants
- K151256: Arthrex BioSync® Bone Wedge (2015), 10 descendants of its own
- K192645: Trigon™ Ti Stand-Alone Wedge Fixation System (2019), 7 descendants of its own
- K193414: Trigon HA Stand-Alone Wedge Fixation System (2020), 6 descendants of its own
- K203445: Trigon HA Stand-Alone Wedge Fixation System (2020), 5 descendants of its own
- K220197: Trigon HA Wedge Fixation System (2022), 4 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 posteriorly stabilization 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, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).

Source page: https://510kreport.com/device/K141635
Methodology: https://510kreport.com/methodology