# K200209: Persona Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 24, 2020 after 56 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: 6 generations back to K933785 (1995). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 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.

## Most influential descendants
- K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (2026), 0 descendants of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 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/K200209
Methodology: https://510kreport.com/methodology