# K081400: Fanning-Pappas Modular Knee Bearing

- Pathway: 510(k) (Traditional)
- Applicant: Endotec, Inc.
- Decided: Feb 20, 2009 after 277 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis avascular necrosis, or previously failed prosthesisjn knees having coi'reitable .vaigus or vars ity, and viable or-reconstrUctable ligaments.

Source page: https://510kreport.com/device/K081400
Methodology: https://510kreport.com/methodology