# K211246: LEGION CR Porous Plus HA Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 24, 2021 after 28 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: 4 generations back to K951987 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091543: Legion Porous Plus HA Primary Femoral Components, Smith & Nephew, Inc. (2009) Summary page 4.

## Indications for use
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Smith & Nephew Legion CR Porous Plus HA Femoral components are indicated for use without bone cement and are single use devices.

Source page: https://510kreport.com/device/K211246
Methodology: https://510kreport.com/methodology