# K061011: Competitor Unicondylar Knee Tibial Baseplate

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 11, 2006 after 90 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912735 (1991). 2 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912735: Genesis Unicompartmental Knee System, Smith & Nephew Richards, Inc. (1991) Summary page 1.
- K030301: Unicondylar Femoral Component, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K152315: JOURNEY II Uni Tibial Base and Insert (2015), 8 descendants of its own
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K191211: JOURNEY II Unicompartmental Knee System (2019), 1 descendant of its own
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K061011
Methodology: https://510kreport.com/methodology