# K032683: Genesis II Porous Plus HA Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 15, 2003 after 47 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 K971206 (1998). 6 ancestors in all.
19 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)
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003)
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000) Summary page 1.
- K023302: Echelon Porous Plus HA Hip Stems, Smith & Nephew, Inc. (2002)

## Most influential descendants
- K100897: Legion Porous + HA Tibial Baseplates (2010), 12 descendants of its own
- K211221: Porous Patella and Porous Tibia Baseplate (2021), 5 descendants of its own
- K190577: World Knee Total Knee Systems (2019), 5 descendants of its own
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- K220737: World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) (2022), 4 descendants of its own

## Indications for use
The Genesis I1 Total Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicornpartmental 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 Genesis I1 Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

Source page: https://510kreport.com/device/K032683
Methodology: https://510kreport.com/methodology