# K160461: Arthrex iBalance BiCompartmental Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 12, 2016 after 53 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K943462 (1994). 35 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073120: Accin Patellofemoral System, Accelerated Innovation, LLC (2008) Summary page 4.
- K063782: Accin Uni-Knee System, Accin Corporation (2007) Summary page 4.
- K060670: Accin Uni-Knee System, Accin Corporation (2006) Summary page 4.
- K090763: Restoris Multicompartmental Knee (MCK) System, Mako Surgical Corporation (2009) Summary page 4.
- K052917: Stryker Compartmental Knee System, Howmedica Osteonics Corp. (2005) Summary page 4.

## Most influential descendants
- K200433: iBalance UKA Tibial Tray Implant (2020), 1 descendant of its own
- K251453: Arthrex iBalance Partial Knee System (2025), 0 descendants of its own
- K171365: Arthrex Knee Systems (2017), 0 descendants of its own

## Indications for use
When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multi-compartmental knee arthroplasty in patients with: Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful partial knee replacement or other procedure; The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee These components are single use only and are intended for implantation with bone cement

Source page: https://510kreport.com/device/K160461
Methodology: https://510kreport.com/methodology