# K121771: Zimmer Persona the Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 7, 2012 after 145 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 75 ancestors in all.
59 later devices descend from it; 9 cite it directly.
0 of 135 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.
- K072160: Nexgen Trabecular Metal Tibial Tray, Zimmer, Inc. (2007) Summary page 1.
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 1.
- K100048: E1 Antioxidant Infused Technology, Biomet Manufacturing Corp (2010) Summary page 1.
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 1.

## Most influential descendants
- K150090: Zimmer Persona Personalized Knee System (2015), 17 descendants of its own
- K172524: Zimmer Persona Personalized Knee System (2018), 15 descendants of its own
- K141635: Arthrex Ibalance Tka System (2014), 15 descendants of its own
- K151256: Arthrex BioSync® Bone Wedge (2015), 10 descendants of its own
- K173417: Zimmer Persona Personalized Knee System (2018), 9 descendants of its own

## Recalls of this device
- May 11, 2016 · Class II · Z-1917-2016: Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.
- Jan 28, 2015 · Class II · Z-1266-2015: An increase in complaints of loosening and radiolucent lines.

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

Source page: https://510kreport.com/device/K121771
Methodology: https://510kreport.com/methodology