# K042271: Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Oct 13, 2004 after 51 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: 2 (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.
16 later devices descend from it; 4 cite it directly.
0 of 24 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.
- K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001) Summary page 1.
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 1.

## Most influential descendants
- K123459: Zimmer Persona TM Personalized Knee System (2013), 9 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
- K222566: Zimmer Persona Personalized Knee System (2022), 2 descendants of its own
- K131310: GMK Full PE Tibial Components (2013), 2 descendants of its own

## Recalls of this device
- Feb 27, 2025 · Class II · Z-1433-2025: The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
- 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
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. The device is indicated for use when both cruciate ligaments have been excised. The device is intended for use as part of a cemented or uncemented knee prosthesis.

Source page: https://510kreport.com/device/K042271
Methodology: https://510kreport.com/methodology