# K122765: Persona Natural Tibia Baseplates

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 9, 2012 after 60 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933785 (1995). 15 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 41 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 1.

## Most influential descendants
- K130143: Persona Natural Tibia Baseplates (2013), 21 descendants of its own
- K172524: Zimmer Persona Personalized Knee System (2018), 15 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K201343: Triathlon Total KneeSystem (2020), 3 descendants of its own

## Recalls of this device
- Dec 12, 2017 · Class II · Z-1224-2018: A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63
- Aug 7, 2017 · Class II · Z-1807-2018: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surf

## 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. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K122765
Methodology: https://510kreport.com/methodology