# K221479: Persona Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 17, 2022 after 178 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). 157 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 166 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.
- K122745: Zimmer Persona the Personalized Knee System, Zimmer, Inc. (2012) Summary page 4.
- K173417: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2018) Summary page 4.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 4.
- K140669: G7 Osseoti Acetublar Shells, Biomet, Inc. (2014) Summary page 4.
- K936159: Natural-Knee II System, Intermedics Orthopedics (1995) Summary page 4.

## Most influential descendants
- K240299: Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) (2024), 3 descendants of its own
- K243293: Zimmer® Persona® Personalized Knee System (2024), 1 descendant of its own
- K251840: Zimmer® Persona® Personalized Knee System (2026), 0 descendants of its own
- K253189: Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (2026), 0 descendants of its own
- K253637: Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (2026), 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 porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension, Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is for uncemented use only. 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/K221479
Methodology: https://510kreport.com/methodology