# K251453: Arthrex iBalance Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 1, 2025 after 50 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: 9 generations back to K943462 (1994). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200433: iBalance UKA Tibial Tray Implant, Arthrex, Inc. (2020) Summary page 6.
- K073120: Accin Patellofemoral System, Accelerated Innovation, LLC (2008) Summary page 6.

## Indications for use
The iBalance UKA System is indicated 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. The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of: • Degenerative arthritis in the distal femur and patella; • A history of patellar dislocation or fracture; • Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement. 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 multicompartmental 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 iBalance 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/K251453
Methodology: https://510kreport.com/methodology