# K181947: Persona Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 25, 2018 after 97 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: 11 generations back to K810258 (1981). 159 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133737: Zimmer (R)  Persona the Personalized Kee System 14X +30MM Tapered Stem Extension, Zimmer, Inc. (2014) Summary page 4.
- K130143: Persona Natural Tibia Baseplates, Zimmer, Inc. (2013) Summary page 4.
- K123459: Zimmer Persona TM Personalized Knee System, Zimmer, Inc. (2013) Summary page 4.
- K122765: Persona Natural Tibia Baseplates, Zimmer, Inc. (2012) Summary page 4.
- K121771: Zimmer Persona the Personalized Knee System, Zimmer, Inc. (2012) Summary page 4.
- K113369: Zimmer Persona Knee System, Zimmer, Inc. (2012) Summary page 4.
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling, Zimmer, Inc. (2018) Summary page 4.
- K152494: Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments, Zimmer, Inc. (2015) Summary page 4.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 5.
- K946150: Cruciate Retaining (Augmentable) and Constrained Condylar Knee (CCK), Zimmer, Inc. (1995) Summary page 5.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 5.
- K103517: Trabecular Metal Femoral Cone Augments, Zimmer Trabecular Metal Technology, Inc. (2011) Summary page 5.
- K040630: Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ, Implex Corp. (2004) Summary page 5.
- K031962: Nexgen Trabecular Metal Tibial Cone Augments, Implex Corp. (2004) Summary page 5.
- K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments, Implex Corp. (2003) Summary page 5.
- K171054: Biomet Knee Joint Replacement Prostheses, Biomet, Inc. (2017) Summary page 5.
- K121149: Vanguard SSK 360 Revision Knee System, Biomet Manufacturing Corp (2012) Summary page 5.
- K093293: Vanguard 360 Revision Knee System, Biomet, Inc. (2010) Summary page 5.
- K042757: Vanguard SSK Knee System, Biomet, Inc. (2005) Summary page 5.
- K023528: Natural-Knee II Cemented Modular Tibial Baseplate, Centerplus Orthopedics, Inc. (2003) Summary page 5.
- K013031: Most Options System, Sulzer Orthopedics, Inc. (2001) Summary page 5.
- K982903: Sulzer Orthopedics Fluted Stems, Sulzer Orthopedics, Inc. (1998) Summary page 5.
- K973412: Natural-Knee II Constrained Knee System, Sulzer Orthopedics, Inc. (1997) Summary page 5.
- K972501: Apollo Revision/Constrained Knee System, Sulzer Orthopedics, Inc. (1997) Summary page 5.

## Most influential descendants
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own
- 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/K181947
Methodology: https://510kreport.com/methodology