# K030612: Genesis II Total Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: May 27, 2003 after 90 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: 1 generation back to K951987 (1995). 2 ancestors in all.
141 later devices descend from it; 9 cite it directly.
0 of 144 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.
- K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 1.

## Most influential descendants
- K032295: Genesis II Posterior Stabilized High Flexion Articular Insert (2003), 76 descendants of its own
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert (2005), 75 descendants of its own
- K071071: Crosslinked Polyethylene Articular Inserts (2007), 66 descendants of its own
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), 60 descendants of its own
- K073325: Legion Porous Primary (2007), 50 descendants of its own

## Indications for use
The porous components of the Genesis I1 Total Knee System are single use devices for use without cement. The devices are indicated for: 1. Rheumatoid arthritis. 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, unicompartmental replacement, or total knee replacement. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posteriorguciate ligaments are incompetent and the collateral ligaments remain intact.

Source page: https://510kreport.com/device/K030612
Methodology: https://510kreport.com/methodology