# K091543: Legion Porous Plus HA Primary Femoral Components

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 21, 2009 after 209 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: 3 generations back to K951987 (1995). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 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 1.

## Most influential descendants
- 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
- K223548: GMK Sphere & GMK SpheriKA Cementless (2023), 1 descendant of its own
- K262057: GMK Extension (2026), 0 descendants of its own
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate tong-term result; failed osteotornies, unicomparimental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.

Source page: https://510kreport.com/device/K091543
Methodology: https://510kreport.com/methodology