# K243293: Zimmer® Persona® Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet
- Decided: Dec 20, 2024 after 63 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 175 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240299: Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella), Zimmer, Inc. (2024) Summary page 6.
- K222566: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2022) Summary page 6.

## Most influential descendants
- 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 personalized 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 Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia. Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona OsseoTi 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/K243293
Methodology: https://510kreport.com/methodology