# K123459: Zimmer Persona TM Personalized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 22, 2013 after 105 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: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 77 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 87 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.
- K121771: Zimmer Persona the Personalized Knee System, Zimmer, Inc. (2012) Summary page 1.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 1.
- K042271: Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces, Zimmer, Inc. (2004) Summary page 1.

## Most influential descendants
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K222566: Zimmer Persona Personalized Knee System (2022), 2 descendants of its own
- K243293: Zimmer® Persona® Personalized Knee System (2024), 1 descendant of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K253637: Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (2026), 0 descendants of its own

## Recalls of this device
- Dec 11, 2014 · Class II · Z-1052-2015: Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, T
- Aug 7, 2014 · Class II · Z-2575-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2577-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2580-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2579-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2578-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2576-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Jun 10, 2013 · Class II · Z-2300-2014: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken ea
- Jun 10, 2013 · Class II · Z-2298-2014: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken ea
- Jun 10, 2013 · Class II · Z-2301-2014: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken ea

## 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/K123459
Methodology: https://510kreport.com/methodology