# K193223: Persona Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 24, 2020 after 63 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 93 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113369: Zimmer Persona Knee System, Zimmer, Inc. (2012) Summary page 4.
- K062768: Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Tivanium TI-6AL-4V Alloy Femoral, Zimmer, Inc. (2006) Summary page 4.
- K172524: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2018) Summary page 4.

## Most influential descendants
- K242543: Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (2024), 0 descendants of its own
- K230078: TRAX® CR Total Knee System (2023), 0 descendants of its own
- K230471: LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (2023), 0 descendants of its own

## Indications for use
When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. When a kinematic alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Moderate valgus, varus, or flexion deformities. The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension. Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Source page: https://510kreport.com/device/K193223
Methodology: https://510kreport.com/methodology