# K011904: Nexgen Primary Porous Patella, Model 04-211-Iiii-5878-65-ZZ-(Standard),04-212-Iiii-5878-61-ZZ-(Micro)

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Jul 19, 2001 after 30 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The NexGen® Primary Porous Patella is intended as the patellar component whose indications for use include: 1) Non-inflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of fractures that are unmanageable using other techniques. This device is intended for use with bone cement.

Source page: https://510kreport.com/device/K011904
Methodology: https://510kreport.com/methodology