# K211471: Balanced Knee System Uni

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Dec 16, 2021 after 219 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 4.
- K191325: EMPOWR Partial Knee, Encore Medical L.P. (2019) Summary page 4.

## Indications for use
1. Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis 2. Traumatic arthritis 3. Previous tibial condyle or plateau fracture with loss of anatomy or function 4. Varus deformities 5. Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged. The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.

Source page: https://510kreport.com/device/K211471
Methodology: https://510kreport.com/methodology