# K070214: Gender Solutions Natural-Knee Flex System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 16, 2007 after 52 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: 63 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933785 (1995). 7 ancestors in all.
123 later devices descend from it; 7 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components, Zimmer, Inc. (2006) Summary page 1.
- P940002: Natural-Knee (R) and Natural Knee (R)II W/Csti (TM), Sulzermedica (1997) Summary page 1.
- K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001) Summary page 1.

## Most influential descendants
- K073286: Gender Solutions Natural-Knee Flex System (2008), 117 descendants of its own
- 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

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1060-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1061-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Oct 8, 2009 · Not classified · Z-0240-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0214-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0221-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0218-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0209-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0252-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0203-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0230-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0226-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0224-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0254-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0244-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0223-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0201-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0248-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0212-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0257-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0208-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0229-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0217-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0222-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0210-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0228-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0227-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0232-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0246-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0237-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0258-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0200-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0220-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0245-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0239-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0207-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0242-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0211-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0250-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0219-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0256-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0213-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0215-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0205-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0225-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0216-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0233-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0204-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0202-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0206-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Oct 8, 2009 · Not classified · Z-0199-2010: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.

## Indications for use
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 porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (UID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K070214
Methodology: https://510kreport.com/methodology