# K122745: Zimmer Persona the Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 5, 2012 after 89 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: 6 generations back to K933785 (1995). 18 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 40 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)
- K072160: Nexgen Trabecular Metal Tibial Tray, Zimmer, Inc. (2007) Summary page 1.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 1.
- K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components, Zimmer, Inc. (2007) Summary page 2.

## Most influential descendants
- K172524: Zimmer Persona Personalized Knee System (2018), 15 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own
- K240299: Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) (2024), 3 descendants of its own
- K201343: Triathlon Total KneeSystem (2020), 3 descendants of its own

## 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 coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

Source page: https://510kreport.com/device/K122745
Methodology: https://510kreport.com/methodology