# K171365: Arthrex Knee Systems

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 7, 2017 after 182 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: 9 generations back to K933785 (1995). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing, Arthrex, Inc. (2016) Summary page 7.
- K160461: Arthrex iBalance BiCompartmental Arthroplasty System, Arthrex, Inc. (2016) Summary page 7.
- K153586: Arthrex iBalance TKA System, Arthrex, Inc. (2016) Summary page 7.
- K152382: Arthrex iBalance TKA System, Arthrex, Inc. (2015) Summary page 7.
- K152252: Arthrex iBalance TKA System, Arthrex, Inc. (2015) Summary page 7.
- K143047: Arthrex iBalance Patella Implant, Dome, Arthrex, Inc. (2014) Summary page 7.
- K133854: Arthrex Ibalance Tka System, Arthrex, Inc. (2014) Summary page 7.
- K073120: Accin Patellofemoral System, Accelerated Innovation, LLC (2008) Summary page 7.
- K063782: Accin Uni-Knee System, Accin Corporation (2007) Summary page 7.
- K060670: Accin Uni-Knee System, Accin Corporation (2006) Summary page 7.

## 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. The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with: *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. 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 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, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation). Arthrex iBalance UKA System is intended 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/K171365
Methodology: https://510kreport.com/methodology