# K050105: Nexgen Complete Knee Solution Distal Femoral Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 17, 2005 after 119 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901240 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030153: Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32, Zimmer, Inc. (2003) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K050105
Methodology: https://510kreport.com/methodology