# K100897: Legion Porous + HA Tibial Baseplates

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 13, 2010 after 43 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 K971206 (1998). 13 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030623: Smith & Nephew Profix Total Knee System, Smith & Nephew, Inc. (2003) Summary page 1.
- K032683: Genesis II Porous Plus HA Knee System, Smith & Nephew, Inc. (2003) Summary page 2.

## Most influential descendants
- K211221: Porous Patella and Porous Tibia Baseplate (2021), 5 descendants of its own
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- 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
- K123159: Smith & Newphew, Inc. Disposable Knee Instruments (2013), 2 descendants of its own
- K173331: JOURNEY II XR Knee Instruments (2017), 1 descendant of its own

## Indications for use
Total knee components are indicated for: 1. Rheumatoid arthritis 2. Post-traumatic arthritis, osteoarthntis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.

Source page: https://510kreport.com/device/K100897
Methodology: https://510kreport.com/methodology