# K953274: Genesis Porous Tibial Trays & Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Feb 5, 1996 after 206 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
161 later devices descend from it; 9 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Genesis I Total Knee System: named in the summary without a submission number
- (no number) NexGen Knee System: named in the summary without a submission number
- (no number) R.F.C. Modular Knee System: named in the summary without a submission number
- (no number) Whiteside Ortholoc II Modular Knee System: named in the summary without a submission number
- (no number) AMK/Coordinate Knee System: named in the summary without a submission number
- (no number) Advantim Knee System: named in the summary without a submission number
- (no number) Kinemax Plus Stabilizer Knee System: named in the summary without a submission number
- (no number) S-ROM Modular Knee System: named in the summary without a submission number

## Most influential descendants
- K030612: Genesis II Total Knee System (2003), 141 descendants of its own
- 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

## Indications for use
The Genesis II Revision System is used for primary and revision surgeries with the following indications 1. Rheumatoid arthritis. 2. 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. 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 I Total Knee System is indicated tor use only with cement and is a single use device.

Source page: https://510kreport.com/device/K953274
Methodology: https://510kreport.com/methodology