# K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 15, 2016 after 244 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- 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 K880155 (1988). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060670: Accin Uni-Knee System, Accin Corporation (2006) Summary page 4.

## Most influential descendants
- K171365: Arthrex Knee Systems (2017), 0 descendants of its own

## Indications for use
The Arthrex iBalance UKA System components are for use in Unicompartmental knee arthroplasty as a result of: * Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; * Correction of functional deformities; * Revision of previous unsuccessful unicompartmental knee replacement or other procedure; * As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K161060
Methodology: https://510kreport.com/methodology