# K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 21, 2007 after 65 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: 4 (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). 6 ancestors in all.
102 later devices descend from it; 4 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 1.
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components, Zimmer, Inc. (2006) Summary page 1.

## Most influential descendants
- K081023: Evolis Total Knee System (2008), 78 descendants of its own
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1044-2018: 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-1057-2018: 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-0840-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Apr 16, 2010 · Not classified · Z-0609-2011: The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolonga

## Indications for use
General Indications for the NexGen Complete Knee Solution Femoral Components: * 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 femoral components may be used cemented or uncemented (biological fixation). Specific Indications for the LPS-Flex Porous Femoral Components: * LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). * Specific uses with the LPS-Flex femorals: - Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. - The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components: * CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). * 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 M Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent 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/K072619
Methodology: https://510kreport.com/methodology