# K972270: Nexgen Complete Knee Solution Convex Inset Patella Component

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 24, 1997 after 166 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Johnson & Johnson Universal Inset Patella: named in the summary without a submission number
- (no number) Insall/Burstein® Patellar Dome: named in the summary without a submission number

## Most influential descendants
- K061433: Vanguard Anatomic Patella Groove  (Apg) / Vanguard V Groove (2006), 0 descendants of its own

## Indications for use
Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, post traumatic loss of joint configuration, particularly when there is patellafemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities. These devices may also be indicated in 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. Intended for cemented use only.

Source page: https://510kreport.com/device/K972270
Methodology: https://510kreport.com/methodology