# K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Oct 17, 2002 after 21 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933785 (1995). 2 ancestors in all.
293 later devices descend from it; 12 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.
- 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
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components (2006), 197 descendants of its own
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components (2003), 193 descendants of its own
- 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

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1047-2018: 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-1049-2018: 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-1050-2018: 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-1046-2018: 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-1048-2018: 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-0831-2016: LDPE bag containing the implant adheres to the highly polished implant surface.

## 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, dyshnction, or prior patellectomy), and moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only Specific uses with CR-Flex femorals: - Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. - The CR-Flex femoral is designed for use with a hnctional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K023211
Methodology: https://510kreport.com/methodology