# K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 28, 2006 after 74 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: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933785 (1995). 3 ancestors in all.
197 later devices descend from it; 6 cite it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 1.

## Most influential descendants
- K070214: Gender Solutions Natural-Knee Flex System (2007), 123 descendants of its own
- K070695: Zimmer Patellofemoral Joint Prosthesis (2007), 122 descendants of its own
- K073286: Gender Solutions Natural-Knee Flex System (2008), 117 descendants of its own
- K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components (2007), 102 descendants of its own
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1059-2018: 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-1056-2018: 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-1058-2018: 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
- Jan 11, 2016 · Class II · Z-0830-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Aug 30, 2013 · Class II · Z-0073-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Aug 30, 2013 · Class II · Z-0074-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Sep 15, 2010 · Not classified · Z-0528-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0529-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0532-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0533-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0534-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0535-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0530-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0531-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Sep 15, 2010 · Not classified · Z-0536-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con
- Jan 27, 2010 · Not classified · Z-0915-2010: The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
- Nov 13, 2009 · Not classified · Z-0501-2010: The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.

## 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. Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: - Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. - The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked™ Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. - The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K060370
Methodology: https://510kreport.com/methodology