# K122529: Zimmer Unicompartmental Knee System Vivacit-E Articular Surface

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 16, 2012 after 88 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 K810258 (1981). 51 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 67 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 1.
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 1.
- K100048: E1 Antioxidant Infused Technology, Biomet Manufacturing Corp (2010) Summary page 2.

## Most influential descendants
- K160738: ZUK Select Knee System (2016), 8 descendants of its own
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- K161592: Persona Partial Knee System (2016), 5 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K212870: TLC Unicompartmental Knee System (2022), 2 descendants of its own

## Indications for use
These devices are indicated for patients with: - Painful and/or disabling kcnee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only. The Zimmer Uriicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K122529
Methodology: https://510kreport.com/methodology