# K191625: Persona Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 5, 2019 after 79 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 160 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181947: Persona Revision Knee System, Zimmer, Inc. (2018) Summary page 4.
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling, Zimmer, Inc. (2018) Summary page 4.
- K013031: Most Options System, Sulzer Orthopedics, Inc. (2001) Summary page 4.
- K982903: Sulzer Orthopedics Fluted Stems, Sulzer Orthopedics, Inc. (1998) Summary page 4.
- K972501: Apollo Revision/Constrained Knee System, Sulzer Orthopedics, Inc. (1997) Summary page 4.

## Most influential descendants
- K210551: Persona Revision Knee System (2021), 0 descendants of its own

## Recalls of this device
- May 11, 2026 · Class II · Z-2578-2026: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

## Indications for use
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. Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

Source page: https://510kreport.com/device/K191625
Methodology: https://510kreport.com/methodology