# K062768: Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Tivanium TI-6AL-4V Alloy Femoral

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Oct 13, 2006 after 28 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991581 (1999). 1 ancestor in all.
25 later devices descend from it; 4 cite it directly.
0 of 27 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.

## Most influential descendants
- K142787: Zimmer Persona Personalized Knee System (2014), 16 descendants of its own
- K172524: Zimmer Persona Personalized Knee System (2018), 15 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own

## 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. Specific uses with 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 ROM is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K062768
Methodology: https://510kreport.com/methodology