# K073286: Gender Solutions Natural-Knee Flex System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 7, 2008 after 107 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933785 (1995). 11 ancestors in all.
117 later devices descend from it; 5 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070214: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2007) Summary page 1.
- K070695: Zimmer Patellofemoral Joint Prosthesis, Zimmer, Inc. (2007) Summary page 1.

## Most influential descendants
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K122765: Persona Natural Tibia Baseplates (2012), 25 descendants of its own
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own

## Recalls of this device
- Jul 10, 2014 · Class II · Z-2583-2014: Zimmer received a trend of complaints indicating corrosion of product.
- Jul 10, 2014 · Class II · Z-2585-2014: Zimmer received a trend of complaints indicating corrosion of product.
- Jul 10, 2014 · Class II · Z-2584-2014: Zimmer received a trend of complaints indicating corrosion of product.
- Jul 10, 2014 · Class II · Z-2582-2014: Zimmer received a trend of complaints indicating corrosion of product.
- Feb 25, 2014 · Class II · Z-1248-2014: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a

## Indications for use
Gender SolutionsTM Natural-Knee®Flex System: · Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). *Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflanmmatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

Source page: https://510kreport.com/device/K073286
Methodology: https://510kreport.com/methodology