# K261462: LANDMARK Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 8, 2026 after 127 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 212 ancestors in all.
No later device cites it as a predicate yet.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073325: Legion Porous Primary, Smith & Nephew, Inc. (2007) Summary page 5.
- 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, Smith & Nephew, Inc. (2023) Summary page 5.
- K121443: Journey II CR Knee System, Smith & Nephew, Inc. (2012) Summary page 5.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 5.
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003) Summary page 6.
- K211221: Porous Patella and Porous Tibia Baseplate, Smith & Nephew, Inc. (2021) Summary page 5.

## Indications for use
The Smith & Nephew LANDMARK Total Knee System is intended for total knee arthroplasty in skeletally mature patients. The LANDMARK CR Porous Femoral component is intended for use with or without bone cement. Indications for Use: * Rheumatoid arthritis * Post-traumatic arthritis, osteoarthritis, or degenerative arthritis * Failed unicompartmental or total knee replacements

Source page: https://510kreport.com/device/K261462
Methodology: https://510kreport.com/methodology