# K073325: Legion Porous Primary

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 20, 2007 after 23 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: 2 generations back to K951987 (1995). 3 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K111711: Journey II BCS Knee System (2011), 40 descendants of its own
- K121443: Journey II CR Knee System (2012), 37 descendants of its own
- K141934: Physica KR Knee System (2015), 18 descendants of its own
- K141471: Journey II XR Knee System (2014), 12 descendants of its own
- K190911: Physica KR Liner and SMR Reverse Humeral Liner (2019), 8 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 long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew Legion Porous Primary femorat components are indicated for use without bone cement and are single use devices.

Source page: https://510kreport.com/device/K073325
Methodology: https://510kreport.com/methodology