# K030301: Unicondylar Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 25, 2003 after 27 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.
30 later devices descend from it; 4 cite it directly.
0 of 31 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) Existing components distributed by Smith & Nephew, Inc.: named in the summary without a submission number

## Most influential descendants
- K073175: Journey Unicondylar Femoral Implant (2007), 26 descendants of its own
- K081351: Modification to Journey Unicondylar Femoral Implant (2008), 18 descendants of its own
- K061011: Competitor Unicondylar Knee Tibial Baseplate (2006), 11 descendants of its own
- K163700: Bodycad Unicompartmental Knee System (2017), 8 descendants of its own
- K160738: ZUK Select Knee System (2016), 8 descendants of its own

## Indications for use
The Unicondylar Femoral Components are indicated for restoring either compartment of a knee that has been affected by the following: 5) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 6) correction of functional deformity; 7) revision procedures where other treatments or devices have failed; and 8) treatment of fractures that are unmanageable using other techniques. The Unicondylar Femoral Components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K030301
Methodology: https://510kreport.com/methodology