# K912735: Genesis Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Dec 27, 1991 after 190 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 9 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102069: Journey Unicondylar Tibial Baseplates (2010), 43 descendants of its own
- K121974: Conformis Iuni Unicondylar Knee Replacement System (2012), 27 descendants of its own
- K073175: Journey Unicondylar Femoral Implant (2007), 26 descendants of its own
- K132640: Iuni Unicondylar Knee Replacement System (2013), 25 descendants of its own
- K081351: Modification to Journey Unicondylar Femoral Implant (2008), 18 descendants of its own

## Recalls of this device
- Jun 21, 2004 · Not classified · Z-0305-05: The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
- Jun 21, 2004 · Not classified · Z-0304-05: The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

Source page: https://510kreport.com/device/K912735
Methodology: https://510kreport.com/methodology