# K042896: Smith & Nephew Hybrid Knee Femoral

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 12, 2005 after 84 days
- Product code: NPJ (Prosthesis, Knee Patellofemorotibial, Partial, 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.
39 later devices descend from it; 3 cite it directly.
0 of 40 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) Genesis I Unicondylar Knee System: named in the summary without a submission number
- (no number) Genesis II Total Knee System: named in the summary without a submission number

## Most influential descendants
- K053488: Conformis Bicompartmental Knee Repair System (2006), 35 descendants of its own
- K063432: Conformis Metal Backed Tibial Component (MBT) (2007), 32 descendants of its own
- K072368: Conformis Metal Backed Tibial Component (2007), 31 descendants of its own
- K072586: Conformis Uni-Condylar Knee System (2007), 30 descendants of its own
- K092441: Modification to: Conformis Iuni Unicondylar Knee Repair System (2009), 29 descendants of its own

## Indications for use
The Hybrid Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee. Indications include: • post-traumatic arthritis; * degenerative arthritis; and * failed osteotomies, hemiarthroplasties; and unicompartmental replacement These indications will be used for the Hybrid Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions. The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement

Source page: https://510kreport.com/device/K042896
Methodology: https://510kreport.com/methodology